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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Comparator: Placebo 5mg (run in); Drug: Donepezil 10 mg; Drug: Donepezil 5 - 10 mg; Drug: Comparator: Placebo 5-10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777608

2008_573

0000-086

Details and patient eligibility

About

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).

Enrollment: 106 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Donepezil 5-10 mg

Experimental group

Description:

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.

Treatment:

Drug: Comparator: Placebo 5mg (run in)

Drug: Donepezil 5 - 10 mg

Drug: Donepezil 10 mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Comparator: Placebo 5-10 mg

Drug: Comparator: Placebo 5mg (run in)

Drug: Donepezil 10 mg