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Acetylcholinesterase Inhibitor

Donepezil for Alzheimer's Effects on Bone Metabolism

Phase 2
Recruiting
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
Must not have
Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab)
Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months

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.
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.
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
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My cognitive test score is below 24.
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I am a woman over 55 or under 55 and haven't had a period in 12 months.
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I have been diagnosed with Alzheimer's or a related dementia based on clinical and either imaging or lab tests.
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I am a man over 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication for osteoporosis.
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I haven't used hormones, seizure meds, blood thinners, or diabetes drugs in the last 6 months.
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I have had a hip fracture, hip replacement, or I cannot walk.
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I have been using corticosteroids for more than 6 months.
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I have a history of Parkinson's, HIV, or Huntington's disease.
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I have had an organ transplant.
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My kidney function is severely impaired.
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I have an active cancer other than non-melanoma skin cancer.
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I am currently taking medication for memory problems.
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I am starting a new or approved drug for amyloid disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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
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
Group II: PlaceboPlacebo Group1 Intervention
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?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,507 Total Patients Enrolled
6 Trials studying Osteoporosis
8,221 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,287 Total Patients Enrolled
23 Trials studying Osteoporosis
12,210 Patients Enrolled for Osteoporosis
Richard H Lee, MD, MPHPrincipal InvestigatorDuke University
~30 spots leftby Jun 2025
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