NCT06041789 · Phase 2 · RECRUITING
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
This trial is testing whether donepezil, an existing memory drug, changes bone health in people with cognitive impairment. Researchers will track bone density, blood markers of bone turnover, and bone quality over 12 months. It is a Phase 2 trial, meaning an early look at effects and safety, not yet proven for this purpose.
You may qualify if
- Diagnosis of cognitive impairment, including clinical assessment, radiographic or labora-tory 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
You're excluded if
- Currently on acetylcholinesterase inhibitor >3 months
- History of bradycardia, heart block, long QT, unexplained syncope, or other contraindica-tion 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, teripar-atide, 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 diseas-es, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthy-roidism (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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-21