← Back to Search
Acetylcholinesterase Inhibitor
Donepezil for Alzheimer's Effects on Bone Metabolism
Durham, NC
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.
See full description
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 belowSelect...
My cognitive test score is below 24.
show original
Select...
I am a woman over 55 or under 55 and haven't had a period in 12 months.
show original
Select...
I have been diagnosed with Alzheimer's or a related dementia based on clinical and either imaging or lab tests.
show original
Select...
I am a man over 50 years old.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication for osteoporosis.
show original
Select...
I haven't used hormones, seizure meds, blood thinners, or diabetes drugs in the last 6 months.
show original
Select...
I have had a hip fracture, hip replacement, or I cannot walk.
show original
Select...
I have been using corticosteroids for more than 6 months.
show original
Select...
I have a history of Parkinson's, HIV, or Huntington's disease.
show original
Select...
I have had an organ transplant.
show original
Select...
My kidney function is severely impaired.
show original
Select...
I have an active cancer other than non-melanoma skin cancer.
show original
Select...
I am currently taking medication for memory problems.
show original
Select...
I am starting a new or approved drug for amyloid disease.
show original
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
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 2023 Phase 4 trial • 132 Patients • NCT0411717865%
various minor non-related events
2%
Hospitalization due to headache
2%
Antebrachium facture
2%
Death
2%
Death due to lung cancer with metastases
2%
Donepezil overdose
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Intervention Arm
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
~2100
Find a Location
Closest Location:Duke Memory Disorders Clinic· Durham, NC
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,493 Previous Clinical Trials
5,908,933 Total Patients Enrolled
6 Trials studying Osteoporosis
7,371 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,834 Previous Clinical Trials
28,184,445 Total Patients Enrolled
23 Trials studying Osteoporosis
11,360 Patients Enrolled for Osteoporosis
Richard H Lee, MD, MPHPrincipal InvestigatorDuke University