Status:
RECRUITING
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Osteoporosis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory biomarker assessment
- Willing to initiate treatment for cognitive impairment
- A) For females: either age \> 55 years, or Age \< 55 years and at least 12 months since last menstrual period B) For males, age \> 50 years
- Geriatric Depression Scale score \< 6
- English-speaking
Exclusion
- Currently on acetylcholinesterase inhibitor or memantine
- History of bradycardia, heart block, long QT, unexplained syncope, or other contraindication for donepezil; subject with ECG showing HR \< 50, PR interval \> 200 ms, QTc \> 440 ms in men or \> 460 ms in women, or evidence of atrioventricular block
- Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, abaloparatide, romozosumab, calcitonin)
- Use of bisphosphonate within last 5 years
- Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
- History of disorders associated with secondary osteoporosis: collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
- History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less
- History of hip fracture, hip replacement, or non-ambulatory
- Long-term use (\>6 months) of corticosteroids
- History of Parkinson's, HIV, Huntington's disease
- History of solid organ transplantation
- History of bariatric surgery or intending to lose weight by bariatric surgery or weight loss medication (e.g. GLP-1 agonist) in the next 12-months
- Severe kidney impairment (eGFR \< 30 ml/min),
- Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer
- 1-year mortality \> 25%, measured by ePrognosis calculator
- Planning to move out of the area in the next 12-months
- Planning surgery in the next 12-months
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06041789
Start Date
February 3 2025
End Date
November 1 2026
Last Update
September 11 2025
Active Locations (1)
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1
Duke Memory Disorders Clinic
Durham, North Carolina, United States, 27705