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

Genetic Risk for Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087865
• Other study ID #: 14-227
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Genetic Risk for Alzheimer's Disease

Intervention

Drug:
• donepezil HCL

• Placebo

Locations

Country	Name	City	State
United States	Cleveland Clinic Center for Brain Health	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 24 Weeks
Primary	Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal	Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.	Baseline and 24 Weeks
Primary	Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal	Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.	Baseline and 24 Weeks
Secondary	Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score	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.	Baseline and 24 Weeks
Secondary	Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume	Left hippocampus volume (MRI) at 24 weeks, adjusting for baseline left hippocampus volume	Baseline and 24 Weeks
Secondary	Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume	Right hippocampus volume (MRI) at 24 weeks, adjusting for baseline right hippocampus volume	Baseline and 24 Weeks
Secondary	Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores	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.	Baseline and 24 Weeks
Secondary	Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores	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.	Baseline and 24 Weeks