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

Primary Purpose

Genetic Risk for Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
donepezil HCL
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Genetic Risk for Alzheimer's Disease

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic Center for Brain Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Donepezil HCL

Placebo

Control Group

Arm Description

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

Participants will receive placebo for 24 weeks.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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
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
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.
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.

Full Information

First Posted
March 7, 2014
Last Updated
August 8, 2023
Sponsor
The Cleveland Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02087865
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Risk for Alzheimer's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donepezil HCL
Arm Type
Active Comparator
Arm Description
Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for 24 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants without a family history of AD will undergo the study evaluations but will not receive any study drug
Intervention Type
Drug
Intervention Name(s)
donepezil HCL
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and 24 Weeks
Title
Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
Description
Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.
Time Frame
Baseline and 24 Weeks
Title
Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
Description
Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.
Time Frame
Baseline and 24 Weeks
Secondary Outcome Measure Information:
Title
Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score
Description
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.
Time Frame
Baseline and 24 Weeks
Title
Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume
Description
Left hippocampus volume (MRI) at 24 weeks, adjusting for baseline left hippocampus volume
Time Frame
Baseline and 24 Weeks
Title
Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume
Description
Right hippocampus volume (MRI) at 24 weeks, adjusting for baseline right hippocampus volume
Time Frame
Baseline and 24 Weeks
Title
Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores
Description
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.
Time Frame
Baseline and 24 Weeks
Title
Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores
Description
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.
Time Frame
Baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Rao, Ph.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Center for Brain Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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