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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Donepezil 5 - 10 mg; Drug: Donepezil 10 mg

• Registration Number: NCT00777608
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Study Start: 2008-12
• Primary Completion: 2009-10
• Study Completion: 2010-04
• Results First Submitted: 2011-01-27
• Results First Submitted QC: 2011-01-27
• Results First Posted: 2011-02-24
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Participant is ambulatory, male or female and 55 years of age or older
• Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

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Exclusion Criteria

• Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
• Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donepezil 5-10 mg	Donepezil 5 - 10 mg	There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Donepezil 5-10 mg	Donepezil 10 mg	There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Placebo	Donepezil 10 mg	There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4	Baseline and 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12	Baseline and 2 weeks, 8 weeks and 12 weeks	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.
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	Baseline and 4 weeks, 8 weeks and 12 weeks.	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.