NCT02087865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

7.6 years

First QC Date

March 7, 2014

Results QC Date

June 29, 2023

Last Update Submit

August 8, 2023

Conditions

Genetic Risk for Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

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

    Baseline and 24 Weeks

  • Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume

    Baseline and 24 Weeks

  • Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume

    Baseline and 24 Weeks

  • Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores

    Baseline and 24 Weeks

  • Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores

    Baseline and 24 Weeks

Study Arms (3)

Donepezil HCL

ACTIVE COMPARATOR

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

Drug: donepezil HCL

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for 24 weeks.

Drug: Placebo

Control Group

NO INTERVENTION

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

Interventions

donepezil HCLDRUG
Donepezil HCL
PlaceboDRUG
Placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Center for Brain Health

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Stephen M. Rao
Organization
Cleveland Clinic
raos2@ccf.org
216 312-4168

Study Officials

  • Stephen M Rao, Ph.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

May 1, 2014

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

August 30, 2023

Results First Posted

August 30, 2023

Record last verified: 2023-08

Locations

US(1)