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Trial record 17 of 562 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

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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

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE May 2014
Estimated Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Change in BOLD response during functional magnetic resonance imaging [ Time Frame: 6 months ]
Changes from baseline to 6 month follow-up fMRI
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02087865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Neuropsychological testing scores [ Time Frame: 6 months ]
Changes in neuropsychological testing scores from baseline to 6 month follow-up visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Official Title  ICMJE Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Genetic Risk for Alzheimer's Disease
Intervention  ICMJE
  • Drug: donepezil HCL
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Donepezil HCL
    Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.
    Intervention: Drug: donepezil HCL
  • Placebo Comparator: Placebo
    Participants will receive placebo for 24 weeks.
    Intervention: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 27, 2020
Estimated Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Danielle Kemeny 216-445-9009 cbhresearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02087865
Other Study ID Numbers  ICMJE 14-227
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Stephen M Rao, Ph.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP