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

Merck Sharp & Dohme LLC106 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Alzheimer's Disease

Interventions

Comparator: Placebo 5mg (run in)DRUG

Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.

Donepezil 5 - 10 mgDRUG

Donepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).

Comparator: Placebo 5-10 mgDRUG

Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days. Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4

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.

Time frame: Baseline and 4 weeks

Secondary Outcomes

Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12

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.

Time frame: Baseline and 2 weeks, 8 weeks and 12 weeks

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

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.

Time frame: Baseline and 4 weeks, 8 weeks and 12 weeks.

Data from ClinicalTrials.gov

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