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

NCT00777608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2015-08-25

Study results available
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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).

Conditions

Interventions

DRUG

Comparator: Placebo 5mg (run in)

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

DRUG

Donepezil 5 - 10 mg

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).

DRUG

Comparator: Placebo 5-10 mg

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).

DRUG

Donepezil 10 mg

Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-10-31
Completion
2010-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777608 on ClinicalTrials.gov