Trial Outcomes & Findings for A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (NCT NCT00934375)

Results Overview

Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

145 participants

Primary outcome timeframe

Baseline, Week 6, Week 12 and Week 28.

Results posted on

2014-01-14

Participant milestones
Measure	Donepezil 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.	Placebo
Overall Study STARTED	68	77
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	13	22

Withdrawal data not reported

A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Baseline characteristics by cohort
Measure	Donepezil n=68 Participants 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.	Placebo n=77 Participants	Total n=145 Participants Total of all reporting groups
Age, Continuous	71.7 years STANDARD_DEVIATION 8.46 • n=5 Participants	73.4 years STANDARD_DEVIATION 8.73 • n=7 Participants	72.6 years STANDARD_DEVIATION 8.62 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants	77 participants n=7 Participants	145 participants n=5 Participants

Timeframe: Baseline, Week 6, Week 12 and Week 28.

Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)

Outcome measures
Measure	Donepezil n=68 Participants 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.	Placebo n=77 Participants
Number of Participants With Treatment-Emergent Adverse Events Any Serious TEAE	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Any Severe TEAE	2 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Any possibly/probably drug-related TEAE	16 Participants	32 Participants
Number of Participants With Treatment-Emergent Adverse Events Any TEAE causing discontinuation of study drug.	7 Participants	17 Participants

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events
Measure	Donepezil n=68 participants at risk 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.	Placebo n=77 participants at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.9% 2/68	0.00% 0/77
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/68	1.3% 1/77
Injury, poisoning and procedural complications Pelvic Fracture	1.5% 1/68	0.00% 0/77
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/68	1.3% 1/77

Other adverse events
Measure	Donepezil n=68 participants at risk 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.	Placebo n=77 participants at risk
Gastrointestinal disorders Diarrhea	5.9% 4/68	15.6% 12/77
Gastrointestinal disorders Nausea	1.5% 1/68	9.1% 7/77
Psychiatric disorders Abnormal dreams	1.5% 1/68	6.5% 5/77
Psychiatric disorders Insomnia	4.4% 3/68	6.5% 5/77
Musculoskeletal and connective tissue disorders Muscle Spasms	8.8% 6/68	9.1% 7/77

Eisai Inc.

Phone: 201-692-1100