RecruitingPhase 2NCT06041789

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


Sponsor

Duke University

Enrollment

45 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether medications used to treat cognitive decline (acetylcholinesterase inhibitors, such as donepezil) also affect bone density and bone health as a side effect — which could be important for patients at risk of osteoporosis. **You may be eligible if...** - You have been diagnosed with cognitive impairment (such as mild cognitive impairment or Alzheimer's disease) - You are planning to start treatment for cognitive impairment - Women must be over 55 or post-menopausal; men must be over 50 - You speak English - You do not currently show signs of significant depression **You may NOT be eligible if...** - You are already taking donepezil, another acetylcholinesterase inhibitor, or memantine - You have heart rhythm problems (such as bradycardia or heart block) that make donepezil unsafe - You are already taking osteoporosis medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonepezil

10 mg tablet

DRUGMemantine

10 mg tablet


Locations(1)

Duke Memory Disorders Clinic

Durham, North Carolina, United States

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NCT06041789


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