Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory 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

Locations
United States
North Carolina
Duke Memory Disorders Clinic
RECRUITING
Durham
Contact Information
Primary
Susanne Danus
susanne.danus@duke.edu
(919) 681-9807
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-11
Participants
Target number of participants: 45
Treatments
Experimental: Donepezil
Active_comparator: Memantine
Sponsors
Leads: Duke University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov