Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

NCT ID
NCT06041789
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Duke University
Conditions
Osteoporosis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 45 participants (Estimated).

What is being studied

  • Intervention: Adamantane
  • Intervention: Amantadine
  • Intervention: Bridged-Ring Compounds
  • Drug: Donepezil
  • Intervention: Donepezil
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Aromatic
  • Intervention: Hydrocarbons, Cyclic
  • Intervention: Indans
  • Intervention: Indenes
  • Drug: Memantine
  • Intervention: Memantine
  • Intervention: Organic Chemicals
  • Intervention: Piperidines
  • Intervention: Polycyclic Aromatic Hydrocarbons
  • Intervention: Polycyclic Compounds

Who may be eligible

Ages
50 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Diagnosis of cognitive impairment, including clinical assessment, radiographic or labora-tory biomarker assessment 2. Willing to initiate treatment for cognitive impairment 3. 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 4. Geriatric Depression Scale score \< 6 5. English-speaking Exclusion Criteria: 1. Currently on acetylcholinesterase inhibitor \>3 months 2. 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 3. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab, calcitonin) 4. Use of bisphosphonate within last 5 years 5. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones 6. History of disorders associated with secondary osteoporosis: collagen vascular diseas-es, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthy-roidism (endogenous or exogenous) 7. History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less 8. History of hip fracture, hip replacement, or non-ambulatory 9. Long-term use (\>6 months) of corticosteroids 10. History of Parkinson's, HIV, Huntington's disease 11. History of solid organ transplantation 12. 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 13. Severe kidney impairment (eGFR \< 30 ml/min), 14. Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer 15. 1-year mortality \> 25%, measured by ePrognosis calculator 16. Planning to move out of the area in the next 12-months 17. Planning surgery in the next 12-months

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • North Carolina, United States: 1

Sample of listed locations

  • Duke Memory Disorders Clinic — Durham, North Carolina, 27705, United States — Recruiting

Study details

Start date
February 3, 2025
Primary completion date
September 1, 2027
Completion date
September 1, 2027
First posted
September 18, 2023
Collaborators
National Institute on Aging (NIA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06041789
Registry last updated
September 21, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06041789 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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