NCT06041789 Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
| NCT ID | NCT06041789 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Duke University |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2025-02-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory 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 or memantine 2. 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 3. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, 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 diseases, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (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
Contact & Investigator
Richard H Lee, MD, MPH
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06041789 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06041789 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06041789 currently recruiting?
Yes, NCT06041789 is actively recruiting participants. Contact the research team at susanne.danus@duke.edu for enrollment information.
Where is the NCT06041789 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06041789 clinical trial?
NCT06041789 is sponsored by Duke University. The principal investigator is Richard H Lee, MD, MPH at Duke University. The trial plans to enroll 45 participants.