Trial Outcomes & Findings for A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase (NCT NCT01278407)

Last Updated: 2023-06-29

Results Overview

The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

142 participants

Primary outcome timeframe

Week 12 for Confirmatory Phase

Results posted on

2023-06-29

Participant Flow

In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.

Participant milestones

Participant milestones
Measure	Placebo - Confirmatory Phase Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.	Placebo to Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.	Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Confirmatory Phase STARTED	46	47	49	0	0
Confirmatory Phase COMPLETED	37	31	43	0	0
Confirmatory Phase NOT COMPLETED	9	16	6	0	0
Extension Phase STARTED	0	0	0	46	96
Extension Phase COMPLETED	0	0	0	34	66
Extension Phase NOT COMPLETED	0	0	0	12	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Confirmatory Phase Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.	Placebo to Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.	Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Confirmatory Phase Adverse Event	5	10	1	0	0
Confirmatory Phase Participant's Choice	3	5	3	0	0
Confirmatory Phase Other	1	1	2	0	0
Extension Phase Adverse Event	0	0	0	7	16
Extension Phase Participant's Choice	0	0	0	4	11
Extension Phase Other	0	0	0	1	3

Baseline Characteristics

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo - Confirmatory Phase n=44 Participants Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase n=45 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase n=49 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.	Total n=138 Participants Total of all reporting groups
Age, Continuous	77.2 Years STANDARD_DEVIATION 6.1 • n=5 Participants	78.8 Years STANDARD_DEVIATION 5.1 • n=7 Participants	77.7 Years STANDARD_DEVIATION 6.8 • n=5 Participants	77.9 Years STANDARD_DEVIATION 6.1 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	80 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	58 Participants n=4 Participants
Mini-Mental State Examination (MMSE) Score	20.3 Unit on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	20.6 Unit on a scale STANDARD_DEVIATION 4.1 • n=7 Participants	20.3 Unit on a scale STANDARD_DEVIATION 4.8 • n=5 Participants	20.4 Unit on a scale STANDARD_DEVIATION 4.3 • n=4 Participants

PRIMARY outcome

Timeframe: Week 12 for Confirmatory Phase

Population: Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.

Outcome measures

Outcome measures
Measure	Placebo - Confirmatory Phase n=44 Participants Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase n=43 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase n=49 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Change From Baseline in Mini-Mental State Examination (MMSE) Score	0.6 Units on a scale Standard Deviation 3.0	1.4 Units on a scale Standard Deviation 3.4	2.2 Units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: Week 12 for Confirmatory Phase

The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation \[reported as cognitive fluctuation inventory\]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.

Outcome measures

Outcome measures
Measure	Placebo - Confirmatory Phase n=44 Participants Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase n=45 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase n=49 Participants Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	-2.0 Units on a scale Standard Deviation 4.2	-1.7 Units on a scale Standard Deviation 4.3	-2.9 Units on a scale Standard Deviation 4.7

Adverse Events

Placebo - Confirmatory Phase

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Donepezil 5 mg - Confirmatory Phase

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Donepezil 10 mg - Confirmatory Phase

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo to Donepezil (5 +10 mg) - Extension Phase

Serious events: 9 serious events

Other events: 31 other events

Deaths: 0 deaths

Donepezil (5 +10 mg) - Extension Phase

Serious events: 12 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Confirmatory Phase n=46 participants at risk Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase n=47 participants at risk Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase n=49 participants at risk Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.	Placebo to Donepezil (5 +10 mg) - Extension Phase n=37 participants at risk Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.	Donepezil (5 +10 mg) - Extension Phase n=96 participants at risk Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Blood and lymphatic system disorders Hypertension	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Cardiac disorders Myocardial infarction	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Eye disorders Cataract	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Decreased appetite	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Inguinal hernia	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Nausea	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Vomiting	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
General disorders Pyrexia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Infections and infestations Bronchitis	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Infections and infestations Pneumonia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Injury, poisoning and procedural complications Femoral neck fracture	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Injury, poisoning and procedural complications Spinal compression fracture	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Nervous system disorders Loss of consciousness	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Hallucination	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Hallucination, visual	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Insomnia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Paranoia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Renal and urinary disorders Renal impairment	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.

Other adverse events

Other adverse events
Measure	Placebo - Confirmatory Phase n=46 participants at risk Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.	Donepezil 5 mg - Confirmatory Phase n=47 participants at risk Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.	Donepezil 10 mg - Confirmatory Phase n=49 participants at risk Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.	Placebo to Donepezil (5 +10 mg) - Extension Phase n=37 participants at risk Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.	Donepezil (5 +10 mg) - Extension Phase n=96 participants at risk Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
General disorders Pyrexia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	6.1% 3/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	3.1% 3/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Infections and infestations Nasopharyngitis	15.2% 7/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.5% 4/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.1% 2/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	48.6% 18/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	17.7% 17/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Injury, poisoning and procedural complications Contusion	8.7% 4/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	16.2% 6/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	7.3% 7/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Renal and urinary disorders Pollakiuria	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	6.4% 3/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	3.1% 3/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Cardiac disorders Angina pectoris	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Eye disorders Conjunctivitis	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Diarrhoea	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	10.8% 4/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	6.2% 6/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Constipation	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.1% 3/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Nausea	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.3% 2/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.1% 3/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.2% 4/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Abdominal discomfort	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Gastritis	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Gastrointestinal disorders Dyspepsia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Hepatobiliary disorders Hepatic function abnormal	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.1% 3/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Infections and infestations Bronchitis	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Investigations Glucose urine present	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.7% 1/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Investigations Blood creatine phosphokinase increased	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.1% 2/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Investigations Weight decreased	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Investigations Lymphocyte count decreased	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Metabolism and nutrition disorders Decreased appetite	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	6.4% 3/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.1% 2/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Metabolism and nutrition disorders Diabetes mellitus	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.1% 2/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Nervous system disorders Parkinsonism	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.3% 2/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.2% 4/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	13.5% 5/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	12.5% 12/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Nervous system disorders Dizziness	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.1% 3/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Nervous system disorders Somnolence	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Agitation	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	3.1% 3/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Insomnia	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	4.3% 2/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.2% 5/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Psychiatric disorders Sleep disorder	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	8.1% 3/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Skin and subcutaneous tissue disorders Eczema	4.3% 2/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	10.8% 4/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Skin and subcutaneous tissue disorders Rash	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.0% 1/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Vascular disorders Hypertension	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
General disorders Irritability	2.2% 1/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 1/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	2.1% 2/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
General disorders Oedema peripheral	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	1.0% 1/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/46 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/47 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/49 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	5.4% 2/37 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.	0.00% 0/96 • For each patient from first dose of study drug administration up to 30 days from last dose of study drug or up to approximately Week 12 for Confirmatory Phase and Week 52 for Extension Phase Safety Analysis Set: The safety analysis set comprised of all patients who received at least one dose and had a postbaseline safety assessment. In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.

Additional Information

Masaki Nakagawa

Eisai Co., Ltd.

Phone: +81-3-3817-5245

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER