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Cholinesterase Inhibitor

Donepezil HCL for Alzheimer's Disease

Phase 4
Waitlist Available
Led By Stephen M Rao, Ph.D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Visual and auditory acuity adequate for neuropsychological testing
Normal general cognitive function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Awards & highlights

Study Summary

This trial looks at how effective donepezil HCL is in detecting Alzheimer's in healthy adults over the age of 65.

Eligible Conditions
  • Alzheimer's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your eyesight and hearing are good enough for cognitive testing.
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You must have normal thinking and memory abilities.
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Only people with a parent or sibling who has Alzheimer's disease are eligible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
Secondary outcome measures
Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores
Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume
Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Donepezil HCLActive Control1 Intervention
Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.
Group II: Control GroupActive Control1 Intervention
Participants without a family history of AD will undergo the study evaluations but will not receive any study drug
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo for 24 weeks.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,364,986 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,004,209 Total Patients Enrolled
Stephen M Rao, Ph.D.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
108 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study pioneering the exploration of a new medical treatment?

"Presently, 14 ongoing studies related to Donepezil HCL are occurring in 17 cities across 7 nations. The primary experiment involving this drug was conducted in 2013 by Dong-A Pharmaceutical Co., Ltd. and involved 210 patients before reaching the Phase 3 clinical trial stage of approval. Since then, an additional 18442 trials have been completed worldwide."

Answered by AI

Is my medical history sufficient to qualify me for participation in this experiment?

"Eligibility criteria for this clinical trial is restricted to those aged 60-75 who have been diagnosed with Alzheimer's disease. A total of 90 patients need to be recruited in order for the study to take place."

Answered by AI

Is this research effort currently taking on new participants?

"Unfortunately, the clinical trial described on clinicaltrials.gov is no longer in recruitment mode. This research project was initially posted on May 1st 2014 and last updated on May 16th 2022; however, 560 other studies are available for participation right now."

Answered by AI

What is the participant capacity for this clinical experiment?

"This medical trial is not presently enrolling participants, though it was initially posted on May 1st 2014 and last updated 5/16/2022. In the case that you are looking for other studies, there exist currently 14 clinical trials involving Donepezil HCL recruiting patients as well as 546 related to Alzheimer's disease."

Answered by AI

Does the participant eligibility criteria for this research include those below thirty years of age?

"Eligible candidates must be aged between 60 and 75. There are 23 trials targeting people younger than 18 whereas 549 studies focus on individuals above 65 years old."

Answered by AI

Has Donepezil HCL been granted regulatory clearance by the FDA?

"Donepezil HCL has been approved and is thus rated a 3 on the safety scale. This Phase 4 trial provides further evidence to support this drug's efficacy."

Answered by AI

For what medical conditions is Donepezil HCL typically prescribed?

"Donepezil HCL has been demonstrated to be effective in treating early-stage alzheimer's disease (AD), mild dementia of the Alzheimer's type, and vascular dementia."

Answered by AI

Are there additional investigations that have utilized Donepezil HCL?

"Currently, there are 14 ongoing trials of Donepezil HCL with two in the late stage 3 classification. Most of these tests are located in Hallandale Beach, FL but there is a breadth of 26 clinical trial sites scattered across the country."

Answered by AI
~8 spots leftby Mar 2025