Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 557 for:    Genetic AND family history

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02087865
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 2014
Estimated Primary Completion Date : February 27, 2020
Estimated Study Completion Date : February 27, 2020


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



Primary Outcome Measures :
  1. Change in BOLD response during functional magnetic resonance imaging [ Time Frame: 6 months ]
    Changes from baseline to 6 month follow-up fMRI


Secondary Outcome Measures :
  1. Neuropsychological testing scores [ Time Frame: 6 months ]
    Changes in neuropsychological testing scores from baseline to 6 month follow-up visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087865


Contacts
Layout table for location contacts
Contact: Danielle Kemeny 216-445-9009 cbhresearch@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Center for Brain Health Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Stephen M Rao, PhD         
Sponsors and Collaborators
The Cleveland Clinic
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Stephen M Rao, Ph.D. The Cleveland Clinic

Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02087865     History of Changes
Other Study ID Numbers: 14-227
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: October 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents