Impact of donepezil on bone health in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of donepezil, an acetylcholinesterase inhibitor, on bone metabolism in individuals diagnosed with Alzheimer's disease-related dementia. Participants will undergo baseline bone density tests and blood sample collections before being randomly assigned to receive either donepezil or a placebo for 12 months. Follow-up assessments will include additional blood samples and repeat bone density tests, along with questionnaires to evaluate their health status throughout the study period. The goal is to understand how donepezil may influence bone mineral density and other factors related to bone health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of cognitive impairment, including clinical assessment, radiographic or labora-tory biomarker assessment
2. Willing to initiate treatment for cognitive impairment
3. 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
4. Geriatric Depression Scale score \< 6
5. English-speaking

Exclusion Criteria:

1. Currently on acetylcholinesterase inhibitor \>3 months
2. 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
3. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab, calcitonin)
4. Use of bisphosphonate within last 5 years
5. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
6. History of disorders associated with secondary osteoporosis: collagen vascular diseas-es, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthy-roidism (endogenous or exogenous)
7. History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less
8. History of hip fracture, hip replacement, or non-ambulatory
9. Long-term use (\>6 months) of corticosteroids
10. History of Parkinson's, HIV, Huntington's disease
11. History of solid organ transplantation
12. 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
13. Severe kidney impairment (eGFR \< 30 ml/min),
14. Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer
15. 1-year mortality \> 25%, measured by ePrognosis calculator
16. Planning to move out of the area in the next 12-months
17. Planning surgery in the next 12-months

Where it's running

• Duke Memory Disorders Clinic
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Richard H Lee, MD, MPH — Duke University
• Study coordinator: Susanne Danus
• Email: susanne.danus@duke.edu
• Phone: (919) 681-9807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.