Trial Outcomes & Findings for A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED) (NCT NCT00777608)

Results Overview

CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

106 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2015-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Donepezil 5-10 mg Participants were randomized to donepezil for 84 days	Placebo Participants were randomized to placebo for 84 days
Overall Study STARTED	53	53
Overall Study COMPLETED	49	47
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Donepezil 5-10 mg Participants were randomized to donepezil for 84 days	Placebo Participants were randomized to placebo for 84 days
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	1	0
Overall Study Investigator Decision	1	2

Baseline Characteristics

A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donepezil 5-10 mg n=53 Participants Participants were randomized to donepezil for 84 days	Placebo n=53 Participants Participants were randomized to placebo for 84 days	Total n=106 Participants Total of all reporting groups
Age, Customized	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).

CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.

Outcome measures

Outcome measures
Measure	Donepezil 5-10 mg n=38 Participants Participants were randomized to donepezil for 84 days	Placebo n=43 Participants Participants were randomized to placebo for 84 days
Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4	-0.10 Score on a scale Standard Error 0.07	-0.07 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and 2 weeks, 8 weeks and 12 weeks

Population: The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).

CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.

Outcome measures

Outcome measures
Measure	Donepezil 5-10 mg n=38 Participants Participants were randomized to donepezil for 84 days	Placebo n=43 Participants Participants were randomized to placebo for 84 days
Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12 Week 2 (N=38, N=43)	-0.2 Score on a scale Standard Error 0.07	-0.006 Score on a scale Standard Error 0.06
Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12 Week 8 (N=38, N=40)	-0.1 Score on a scale Standard Error 0.07	-0.02 Score on a scale Standard Error 0.07
Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12 Week 12 (N=38, N=41)	-0.2 Score on a scale Standard Error 0.07	-0.09 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and 4 weeks, 8 weeks and 12 weeks.

Population: The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).

The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline.

Outcome measures

Outcome measures
Measure	Donepezil 5-10 mg n=38 Participants Participants were randomized to donepezil for 84 days	Placebo n=43 Participants Participants were randomized to placebo for 84 days
Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12 Week 4 (N=38, N=43)	0.2 Score on a scale Standard Error 0.8	-0.3 Score on a scale Standard Error 0.7
Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12 Week 8 (N=37, N=40)	0.07 Score on a scale Standard Error 1.0	-0.7 Score on a scale Standard Error 1.0
Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12 Week 12 (N=38, N=40)	-1.4 Score on a scale Standard Error 1.0	-1.0 Score on a scale Standard Error 1.0

Adverse Events

Donezepil 5-10 mg

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Donezepil 5-10 mg n=53 participants at risk Participants were randomized to donepezil for 84 days	Placebo n=53 participants at risk Participants were randomized to placebo for 84 days
Gastrointestinal disorders Inguinal hernia	1.9% 1/53	0.00% 0/53
Injury, poisoning and procedural complications Head Injury	1.9% 1/53	0.00% 0/53
Injury, poisoning and procedural complications Subdural haematoma	1.9% 1/53	0.00% 0/53
Nervous system disorders Convulsion	1.9% 1/53	0.00% 0/53
Renal and urinary disorders Urinary incontinence	1.9% 1/53	0.00% 0/53

Other adverse events

Other adverse events
Measure	Donezepil 5-10 mg n=53 participants at risk Participants were randomized to donepezil for 84 days	Placebo n=53 participants at risk Participants were randomized to placebo for 84 days
Gastrointestinal disorders Nausea	13.2% 7/53	9.4% 5/53
Nervous system disorders Dizziness	5.7% 3/53	7.5% 4/53

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp and Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place