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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Participants will also complete questionnaires at each study visit."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how donepezil affects bone strength and how bone breaks down and rebuilds in people with memory or thinking problems. Participants take donepezil by mouth each day for 12 months and have bone density tests, blood tests, and questionnaires.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have diagnosed memory or thinking problems, assessed with exams, scans, or lab tests.
- Be willing to start treatment for memory or thinking problems.
- Women must be older than 55, or younger than 55 with no menstrual period for at least 12 months.
- Men must be older than 50.
- Score below 6 on the Geriatric Depression Scale, a questionnaire about depression.
- Speak English.
Who can't join
- Have taken an acetylcholinesterase inhibitor, a type of memory medicine, for more than 3 months; or have certain heart rhythm problems, unexplained fainting, or another reason donepezil is unsafe.
- Currently take medicine for osteoporosis (weak bones), or have used a bisphosphonate bone medicine in the past 5 years. Also excluded: certain hormone treatments, seizure medicines, heparin, or thiazolidinedione diabetes medicines in the past 6 months.
- Have certain illnesses that can weaken bones, including connective tissue disease, poor nutrient absorption, inflammatory bowel disease, severe liver disease, or an overactive thyroid; or have used steroid medicines for more than 6 months.
- Have broken the upper arm, wrist, or spine after a fall from standing height or lower; have had a hip fracture or hip replacement; or cannot walk.
- Have Parkinson's disease, HIV, Huntington's disease, a past organ transplant, or severe kidney problems (eGFR below 30, a measure of kidney function).
- Have had weight-loss surgery, or plan weight-loss surgery or weight-loss medicine in the next 12 months.
- Have cancer being treated with chemotherapy, surgery, or radiation, except non-melanoma skin cancer; or have a calculated chance of death above 25% within one year.
- Plan to move out of the area or have surgery in the next 12 months.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
NC
- Duke Memory Disorders Clinic · Durham, NC 27705Connie Thacker · Study contactMore trials in Durham