Completed

NCT Number: NCT02087865

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

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.

Completed

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Key information

Conditions

Genetic Risk for Alzheimer's Disease

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Center for Brain Health

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil HCl

Drug

Placebo

Drug

Primary outcomes

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

Time frame: Baseline and 24 Weeks

Changes from baseline to 24 weeks follow-up fMRI - Left posterior cingulate BOLD signal at 24 weeks, adjusting for baseline left posterior cingulate BOLD signal.
Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame: Baseline and 24 Weeks

Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.
Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame: Baseline and 24 Weeks

Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.

Secondary outcomes

Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score

Time frame: Baseline and 24 Weeks

Rey Auditory Verbal Learning Test (RAVLT) (Sum of Trials 1-5) , adjusting for baseline RAVLT (Sum of Trials 1-5) score. The RAVLT total score has a minimum of 0 and a maximum of 75 correct items (15 per trial x 5 trials). A higher score means better outcomes.
Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume

Time frame: Baseline and 24 Weeks

Left hippocampus volume (MRI) at 24 weeks, adjusting for baseline left hippocampus volume
Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume

Time frame: Baseline and 24 Weeks

Right hippocampus volume (MRI) at 24 weeks, adjusting for baseline right hippocampus volume
Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores

Time frame: Baseline and 24 Weeks

Brief Visuospatial Memory Test (BVMT) learning scores at 24 weeks, adjusted for baseline BVMT learning scores. The BVMT-R total scare has a minimum of 0 and a maximum of 36 correct items (12 per trial x 3 trials). A higher score means better outcomes.
Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores

Time frame: Baseline and 24 Weeks

Processing speed test (PST) at 24 weeks, adjusting for baseline PST scores. The PST has a minimum of 0 and no upper limit/maximum since it is the number of correct items in 2 minutes. A higher score means better outcome.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

National Institute on Aging (NIA)

Registry information

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Mar 14, 2014
Registry last updated: Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.