Clinical trial NCT02087865: Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Official title: Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genetic Risk for Alzheimer's Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-03-14
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BOLD Response From Baseline to 24 Weeks During Functional Magnetic Resonance Imaging - Left Posterior Cingulate BOLD Signal at 24 Weeks, Adjusting for Baseline Left Posterior Cingulate BOLD
timeFrame: Baseline and 24 Weeks
measure: Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
timeFrame: Baseline and 24 Weeks
measure: Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score
timeFrame: Baseline and 24 Weeks
measure: Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume
timeFrame: Baseline and 24 Weeks
measure: Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume
timeFrame: Baseline and 24 Weeks
measure: Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores
timeFrame: Baseline and 24 Weeks
measure: Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores
timeFrame: Baseline and 24 Weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Brain Health
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stephen M Rao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: