Actively Recruiting
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Led by Duke University · Updated on 2025-09-11
45
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality. Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching memantine to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.
CONDITIONS
Official Title
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cognitive impairment confirmed by clinical, imaging, or laboratory biomarker assessment
- Willingness to start treatment for cognitive impairment
- For females: age over 55 years, or under 55 years and at least 12 months since last menstrual period; For males: age over 50 years
- Geriatric Depression Scale score less than 6
- English speaking
You will not qualify if you...
- Currently taking acetylcholinesterase inhibitors or memantine
- History of bradycardia, heart block, long QT, unexplained syncope, or other contraindications for donepezil; ECG showing heart rate below 50, PR interval over 200 ms, QTc over 440 ms in men or over 460 ms in women, or atrioventricular block
- Currently using osteoporosis medications such as bisphosphonates, SERMs, denosumab, teriparatide, abaloparatide, romosozumab, or calcitonin
- Use of bisphosphonates within the last 5 years
- Use of estrogens, testosterone, androgen deprivation therapy, aromatase inhibitors, antiepileptics, heparin therapy, or thiazolidinediones within the last 6 months
- History of disorders linked to secondary osteoporosis, including collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver disease or cirrhosis, hyperthyroidism
- History of fractures in the humerus, wrist, or vertebra from a fall at standing height or less
- History of hip fracture, hip replacement, or being non-ambulatory
- Long-term corticosteroid use over 6 months
- History of Parkinson's disease, HIV, or Huntington's disease
- History of solid organ transplantation
- History of or planned bariatric surgery or weight loss medication use in the next 12 months
- Severe kidney impairment with eGFR below 30 ml/min
- Active cancer undergoing treatment, except non-melanoma skin cancer
- Expected mortality over 25% in 1 year based on ePrognosis calculator
- Planning to move away from the area within 12 months
- Planning surgery within 12 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke Memory Disorders Clinic
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
S
Susanne Danus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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