Effect of donepezil on bone metabolism among older adults with Alzheimer's disease.

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-11-18 DOI:10.1016/j.cct.2024.107748

Rebecca North, Andy J Liu, Carl Pieper, Susanne Danus, Connie R Thacker, Marissa Ashner, Cathleen Colón-Emeric, Richard H Lee

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Abstract

Older adults with Alzheimer's disease (AD), in addition to significant cognitive disability, have twice the risk of fracture compared to those with normal cognition. Fractures among older adults with AD are associated with substantial morbidity, loss of physical function, and significant mortality. Prior studies have shown a decreased risk of fracture among those taking acetylcholinesterase inhibitors, such as donepezil. With both cognitive and non-cognitive benefits, donepezil would be a valuable component in a fracture prevention program for older adults with AD. Though anti-amyloid therapies are now clinically available, donepezil may still have non-cognitive benefits. However, the specific effects of donepezil on bone metabolism are unknown. We have designed this randomized, double-blind, placebo-controlled clinical trial to investigate the effect of AD treatment with donepezil on bone metabolism. The study will measure the change in bone mineral density, bone turnover markers, and bone quality related to 12-months of donepezil therapy. This will be the first known study of changes in bone metabolism among older adults with AD.

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多奈哌齐对老年痴呆症患者骨代谢的影响。

与认知能力正常的老年人相比，患有阿尔茨海默病（AD）的老年人除了有严重的认知障碍外，骨折的风险也是后者的两倍。患有阿尔茨海默病（AD）的老年人发生骨折会导致严重的发病率、身体功能丧失和死亡率。先前的研究表明，服用乙酰胆碱酯酶抑制剂（如多奈哌齐）的患者骨折风险降低。多奈哌齐在认知和非认知方面均有益处，因此将成为注意力缺失症老年人骨折预防计划的重要组成部分。虽然抗淀粉样蛋白疗法目前已可在临床上使用，但多奈哌齐可能仍有非认知方面的益处。然而，多奈哌齐对骨代谢的具体影响尚不清楚。我们设计了这项随机、双盲、安慰剂对照临床试验，以研究多奈哌齐治疗老年痴呆症对骨代谢的影响。该研究将测量与多奈哌齐治疗 12 个月相关的骨矿物质密度、骨转换标志物和骨质量的变化。这将是已知的第一项关于患有注意力缺失症的老年人骨代谢变化的研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.