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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02087865
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 106.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genetic Risk for Alzheimer's Disease	Drug: donepezil HCL; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
• Actual Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Donepezil HCL Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.	Drug: donepezil HCL
Placebo Comparator: Placebo Participants will receive placebo for 24 weeks.	Drug: Placebo
No Intervention: Control Group Participants without a family history of AD will undergo the study evaluations but will not receive any study drug

Outcome Measures

Primary Outcome Measures

1. Change in BOLD response during functional magnetic resonance imaging [6 months]

   Changes from baseline to 6 month follow-up fMRI

Secondary Outcome Measures

1. Neuropsychological testing scores [6 months]

   Changes in neuropsychological testing scores from baseline to 6 month follow-up visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Center for Brain Health	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Stephen M Rao, Ph.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02087865
• Other Study ID Numbers: 14-227
• First Posted: Mar 14, 2014
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Additional relevant MeSH terms: Alzheimer Disease; Donepezil

Study Results

No Results Posted as of May 18, 2022