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Phase 4 N=89 Randomized Triple-blind Other

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

Genetic Risk for Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02087865 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: 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 — 44.68; 50.61; 45.57 100 * % Signal Change — p=0.273

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
donepezil HCL (Drug); Placebo (Drug)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
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		 44.68; 50.61; 45.57 0.273
PRIMARY
Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal		 19.91; 32.31; 19.38 0.001 sig
PRIMARY
Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal		 24.9; 32.78; 26.73 0.115
SECONDARY
Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score		 52.86; 53.58; 51.41 0.941
SECONDARY
Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume		 3309.51; 3289.36; 3296.68 0.003 sig
SECONDARY
Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume		 1810.88; 1756.92; 3363.62 <0.001 sig
SECONDARY
Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores		 21.41; 23.58; 23.28 0.005 sig
SECONDARY
Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores		 44.17; 49.8; 47.73 0.011 sig

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02087865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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