Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease

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

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2021-12-20

Brief Summary

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This study examines the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease.

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Detailed Description

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This 24-week study will examine the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be eligible for this study. Participants without a family history of AD will also be enrolled to serve as a control group.

Conditions

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Genetic Risk for Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Donepezil HCL

Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.

Group Type ACTIVE_COMPARATOR

donepezil HCL

Intervention Type DRUG

Placebo

Participants will receive placebo for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control Group

Participants without a family history of AD will undergo the study evaluations but will not receive any study drug

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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donepezil HCL

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal general cognitive function
* High Risk Group Only: Family history (1st degree relative) of AD
* Low Risk Group Only: No family history (1st or 2nd degree relative) of AD
* Visual and auditory acuity adequate for neuropsychological testing

Exclusion Criteria

* Current or past history of
* neurological illnesses/conditions
* head trauma with significant loss of consciousness
* medical illnesses/conditions that may affect brain function
* severe psychiatric disorder
* substance abuse
* unstable or severe cardiovascular disease or asthmatic condition
* history of stroke or transient ischemic attack

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes