NCT06041789RecruitingPhase 2
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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 assigned to donepezil 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 11 Sept 2023
- Start date
- 3 Feb 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Duke University
- Diseases
- Alzheimer disease, Osteoporosis
- NCT number
- NCT06041789
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 3 Feb 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on acetylcholinesterase inhibitor \>3 months
- Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab, calcitonin)
- Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
- Long-term use (\>6 months) of corticosteroids
- Planning surgery in the next 12-months
Other illness
- 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
- 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
- Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer
Lab values
- 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
- Severe kidney impairment (eGFR \< 30 ml/min),
Other
- Use of bisphosphonate within last 5 years
- 1-year mortality \> 25%, measured by ePrognosis calculator
- Planning to move out of the area in the next 12-months
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Memory Disorders Clinic Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.