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Acetylcholinesterase Inhibitor

Donepezil for Alzheimer's Effects on Bone Metabolism

Q: Has Donepezil been endorsed as a valid form of treatment by the FDA?

<p>Our team's evaluation of Donepezil's safety is a 2, as the clinical trial in question only has data confirming its relative security. There is no evidence to support that it will be effective at this stage.</p>

Q: Are there any openings left for participants in this research project?

<p>Clinicaltrials.gov lists this medical trial as 'not yet recruiting', despite being first posted on September 1st 2023 and last updated on the 11th of that same month. However, 139 other studies are presently enrolling patients into their trials.</p>

Phase 2

Waitlist Available

Led By Richard H Lee, MD, MPH

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MoCA score < 24

For females, either age > 55 years, or Age < 55 years and at least 12 months since last menstrual period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

Study Summary

This trial studies how donepezil affects bone metabolism factors in people with Alzheimer's.

Who is the study for?

This trial is for people with Alzheimer's who are at risk of osteoporosis. Women over 55 or postmenopausal, men over 50, and those willing to start treatment can join. Exclusions include current use of certain bone-related drugs, recent hormone treatments, severe liver disease or kidney impairment, and other specific health conditions.Check my eligibility

What is being tested?

The study tests if Donepezil affects bone health in Alzheimer's patients compared to a placebo. Participants will take the drug or placebo for a year with blood tests and bone density scans at the beginning, middle, and end to measure changes in their bones.See study design

What are the potential side effects?

Donepezil may cause side effects like nausea, diarrhea, insomnia, muscle cramps, fatigue and occasionally more serious heart-related issues. The exact side effects on bone metabolism are what this trial aims to discover.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cognitive test score is below 24.

Select...

I am a woman over 55 or under 55 and haven't had a period in 12 months.

Select...

I have been diagnosed with Alzheimer's or a related dementia based on clinical and either imaging or lab tests.

Select...

I am a man over 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months 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 bone mineral density, as measured by dual x-ray absorptiometry (DXA)

Secondary outcome measures

Change in Trabecular Bone score

Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)

Change in bone resorption marker C-terminal telopeptide (CTX)

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671

Suicide Attempt

Myocardial infarcation with congestive heart failure

stroke

100%

80%

60%

40%

20%

Study treatment Arm

Donepezil

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DonepezilExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donepezil

2011

Completed Phase 4

~2070

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,024 Total Patients Enrolled

6 Trials studying Osteoporosis

8,221 Patients Enrolled for Osteoporosis

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,005,069 Total Patients Enrolled

22 Trials studying Osteoporosis

12,223 Patients Enrolled for Osteoporosis

Richard H Lee, MD, MPHPrincipal InvestigatorDuke University

Frequently Asked Questions

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

Has Donepezil been endorsed as a valid form of treatment by the FDA?

"Our team's evaluation of Donepezil's safety is a 2, as the clinical trial in question only has data confirming its relative security. There is no evidence to support that it will be effective at this stage."

Answered by AI

Are there any openings left for participants in this research project?

"Clinicaltrials.gov lists this medical trial as 'not yet recruiting', despite being first posted on September 1st 2023 and last updated on the 11th of that same month. However, 139 other studies are presently enrolling patients into their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

2024. "Effect of Acetylcholinesterase Inhibitors on Bone Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041789.

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