[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06041789":3,"trial-entities:NCT06041789":89,"trial-summary:NCT06041789":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":41,"sex":51,"minimum_age":52,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":74,"overall_officials":79,"references":83,"see_also_links":88},"NCT06041789","Pro00111080","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","RECRUITING","2026-11","2025-09","2025-09-11","2025-02-03","Duke University","OTHER",false,"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.\n\nParticipants 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.",null,[19],"Osteoporosis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},45,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Donepezil","10 mg tablet",[31],{"type":30,"name":35,"description":32,"armGroupLabels":36},"Memantine",[35],[38],{"measure":39,"timeFrame":40},"Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)","baseline, 12 months",[42,46,48],{"measure":43,"description":44,"timeFrame":45},"Change in bone resorption marker C-terminal telopeptide (CTX)","measured using commercially available ELISA test on serum","baseline, 6 months, 12 months",{"measure":47,"description":44,"timeFrame":45},"Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)",{"measure":49,"description":50,"timeFrame":40},"Change in Trabecular Bone score","measure of bone quality, using DXA spine images","ALL","50 Years",{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria:\n\n1. Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory biomarker assessment\n2. Willing to initiate treatment for cognitive impairment\n3. A) For females: either age \\> 55 years, or Age \\\u003C 55 years and at least 12 months since last menstrual period B) For males, age \\> 50 years\n4. Geriatric Depression Scale score \\\u003C 6\n5. English-speaking\n\nExclusion Criteria:\n\n1. Currently on acetylcholinesterase inhibitor or memantine\n2. History of bradycardia, heart block, long QT, unexplained syncope, or other contraindication for donepezil; subject with ECG showing HR \\\u003C 50, PR interval \\> 200 ms, QTc \\> 440 ms in men or \\> 460 ms in women, or evidence of atrioventricular block\n3. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, abaloparatide, romozosumab, calcitonin)\n4. Use of bisphosphonate within last 5 years\n5. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones\n6. History of disorders associated with secondary osteoporosis: collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver disease\u002Fcirrhosis, hyperthyroidism (endogenous or exogenous)\n7. History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less\n8. History of hip fracture, hip replacement, or non-ambulatory\n9. Long-term use (\\>6 months) of corticosteroids\n10. History of Parkinson's, HIV, Huntington's disease\n11. History of solid organ transplantation\n12. 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\n13. Severe kidney impairment (eGFR \\\u003C 30 ml\u002Fmin),\n14. Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer\n15. 1-year mortality \\> 25%, measured by ePrognosis calculator\n16. Planning to move out of the area in the next 12-months\n17. Planning surgery in the next 12-months",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":71},"Duke Memory Disorders Clinic","Durham","North Carolina","27705","United States",[68],{"name":69,"role":70},"Connie Thacker","CONTACT",{"lat":72,"lon":73},35.99403,-78.89862,[75],{"name":76,"role":70,"phone":77,"email":78},"Susanne Danus","(919) 681-9807","susanne.danus@duke.edu",[80],{"name":81,"affiliation":13,"role":82},"Richard H Lee, MD, MPH","PRINCIPAL_INVESTIGATOR",[84],{"pmid":85,"type":86,"citation":87},"39566720","DERIVED","North R, Liu AJ, Pieper C, Danus S, Thacker CR, Ashner M, Colon-Emeric C, Lee RH. Effect of donepezil on bone metabolism among older adults with Alzheimer's disease. Contemp Clin Trials. 2025 Jan;148:107748. doi: 10.1016\u002Fj.cct.2024.107748. Epub 2024 Nov 19.",[],{"nct_id":4,"conditions":90,"biomarkers":91},[19],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This study plans to enroll 45 participants. You will be randomly assigned to receive either donepezil or memantine daily for 12 months.","completed","Donepezil and Memantine for Bone Health in Cognitive Impairment","This study is looking at how two common medications, donepezil and memantine, affect bone health in people with cognitive impairment (problems with thinking and memory). We know that people with Alzheimer's disease have a higher risk of bone fractures, and some studies suggest donepezil might help reduce this risk, but we don't know why. This study aims to measure how donepezil affects your bone mineral density (how strong your bones are) and other factors related to bone health. You can join if you are aged 50 or older, have a diagnosis of cognitive impairment, and are willing to start treatment for it. The study will measure changes in your bone mineral density over 12 months to see if these medications have an effect. The current status of this study is unclear.","Your bone mineral density will be measured at baseline and again at 12 months.",131,"You will have a bone density test and blood samples collected at the start. You will also have blood samples collected at 6 and 12 months, and another bone density test at 12 months. You will complete questionnaires at each visit.","Not stated in the trial record.",[31,35],"v2"]