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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Comparator: Placebo 5mg (run in)

Intervention Type DRUG

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

Donepezil 5 - 10 mg

Intervention Type DRUG

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).

Donepezil 10 mg

Intervention Type DRUG

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo 5mg (run in)

Intervention Type DRUG

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

Comparator: Placebo 5-10 mg

Intervention Type DRUG

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).

Donepezil 10 mg

Intervention Type DRUG

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

Interventions

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Comparator: Placebo 5mg (run in)

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

Intervention Type 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).

Intervention Type 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).

Intervention Type DRUG

Donepezil 10 mg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No