Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Currently on acetylcholinesterase inhibitor or memantine
- •History of bradycardia, heart block, long QT, unexplained syncope, or other contraindication 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
- •Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, abaloparatide, romozosumab, calcitonin)
- •Use of bisphosphonate within last 5 years
- •Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
- •History of disorders associated with secondary osteoporosis: collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
- •History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less
- •History of hip fracture, hip replacement, or non-ambulatory
- •Long-term use (>6 months) of corticosteroids
- •History of Parkinson's, HIV, Huntington's disease
- •History of solid organ transplantation
- •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
- •Severe kidney impairment (eGFR < 30 ml/min),
- •Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer
- •1-year mortality > 25%, measured by ePrognosis calculator
- •Planning to move out of the area in the next 12-months
- •Planning surgery in the next 12-months
研究组 & 干预措施
Donepezil
干预措施: Donepezil (Drug)
Memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
时间窗: baseline, 12 months
次要结局
- Change in Trabecular Bone score(baseline, 12 months)
- Change in bone resorption marker C-terminal telopeptide (CTX)(baseline, 6 months, 12 months)
- Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)(baseline, 6 months, 12 months)