Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06041789
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Donepezil — DRUG
    10 mg tablet
  • Memantine — DRUG
    10 mg tablet

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donepezil
  • Active Comparator: Memantine

Primary Outcome Measure

Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA) [ Time Frame: baseline, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Memory Disorders ClinicDurhamNorth Carolina27705
Connie Thacker

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By research site
Duke Memory Disorders Clinic· Durham, NC

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