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Acetylcholinesterase Inhibitor

Donepezil for Alzheimer's Disease

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 8
Awards & highlights

Study Summary

This trial will test whether donepezil (MK-0000) can improve cognitive function in people with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD) compared to placebo. The primary study hypothesis is that participants receiving donepezil will get ≥2 percentage points more correct responses on one card learning (OCL) task than participants receiving placebo.

Eligible Conditions
  • Alzheimer's Disease
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Change From Baseline in Correct Responses on the One Card Learning (OCL) Task to Week 8
Secondary outcome measures
Percentage Change From Baseline in the Overall Standard Deviation (sd) in Average OCL Task (Arcsine Square Root Transformed) to Week 8
Percentage of Correct Responses on the OCL Task

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671
1%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonepezilExperimental Treatment1 Intervention
Participants receive donepezil in doses up to 10 mg once daily (QD), orally in a scheduled titration for Days 1-56. The total treatment duration is 56 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo QD, orally for Days 1-56. The total treatment duration is 56 Days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donepezil
2011
Completed Phase 4
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,784 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,613 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,443 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 popular in Canada?

"There are seven different locations currently recruiting patients for this trial. For example, Insight Clinical Trials (Site 0020) in Beachwood, North Texas Clinical Trials - Fort Worth - West Rosedale (Site 0022) in Fort Worth, and Charter Research - Lady Lake ( Site 0025) in Lady Lake."

Answered by AI

How many people are participating in this test of the new drug?

"36 patients that meet the clinical trial's inclusion criteria are required in order for the study to proceed as planned. Merck Sharp & Dohme Corp., the sponsor of the trial, will be running it from various locations including Insight Clinical Trials ( Site 0020) in Beachwood, Ohio and North Texas Clinical Trials - Fort Worth - West Rosedale ( Site 0022) in Fort Worth, Texas."

Answered by AI

Are there any life-threatening risks associated with Donepezil?

"There is only limited data supporting the safety and efficacy of Donepezil, so it received a score of 1."

Answered by AI

What are the effects of Donepezil on patients?

"Donepezil is a popular medication for managing Alzheimer's disease. Additionally, it can also help patients that suffer from mild dementia of the Alzheimer's type, vascular dementia, and general dementia."

Answered by AI

Could you pre-screen me to see if I am eligible for this clinical trial?

"The prerequisites for being accepted into this trial are that the applicant has Alzheimer's disease and is between the ages of 55 and 85. Out of the total 36 people who can participate in the clinical trial, how many candidates will be admitted?"

Answered by AI

What is the medical research history of Donepezil?

"At this time, there are 16 clinical trials for donepezil underway, with 3 in Phase 3. Most of these studies are taking place in Hallandale Beach, Florida; however, there are a total of 31 locations running trials for this medication."

Answered by AI

Is this a novel clinical trial?

"Since 2013, Donepezil has undergone clinical trials sponsored by Dong-A Pharmaceutical Co., Ltd. After the first Phase 3 drug approval in 2013, which required 210 patients, 16 more live trials have followed across 21 cities and 7 countries."

Answered by AI

Does this research project welcome seniors as participants?

"The age requirements to participate in this trial are between 55-85 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
2021. "Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04730635.
~11 spots leftby Apr 2025
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