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Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

StatusRecruiting
PhasePhase 2
Started2025-02-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Nov 2026 → Sep 2027
See other at-risk trials from Duke University

Amendment history

2026-09-22
Primary completion pushed: 2026-11 → 2027-09
Completion pushed: 2026-11 → 2027-09
2025-09-05
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v7
Primary completion date2025-06→2026-11
Completion date2025-06→2026-11
InterventionsDonepezil (Drug), Placebo (Drug)→Donepezil (Drug), Memantine (Drug)
Eligibility criteria+598 characters
Inclusion Criteria: Diagnosis of ADRDcognitive impairment, including clinical assessment and either, radiographic or laboratory biomarker assessment Meets NIA-AA clinical dementia criteria Willing to initiate treatment with AchEI for ADRDcognitive impairment MoCAA) score < 24 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 Exclusion Criteria: Currently on acetylcholinesterase inhibitor or memantine History of bradycardia, heart block, long QT, unexplained [...] [...]
2025-02-04
Study Status v6
Start dateestimated 2024-10→confirmed 2025-02-03
2024-10-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2024-08-31→2024-10
Study sitesdetails revised at 1 of 1 site
2024-07-11
Study Status v4
Start date2024-07→2024-08-31
Show 3 earlier versions
2024-05-17
Study Status v3
Primary completion date2025-03→2025-06
Completion date2025-03→2025-06
Start date2024-03-31→2024-07
2024-02-19
Study Status v2
Start date2023-12-04→2024-03-31
2023-10-24
Study Status v1
Start date2023-09→2023-12-04
2023-09-11
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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.
Trial Details
NCT Number NCT06041789
Lead Sponsor Duke University
Collaborators: National Institute on Aging (NIA)
Conditions Osteoporosis
Enrollment 45 participants
Start Date 2025-02-03
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-21