Adverse effects of methylphenidate for apathy in patients with Alzheimer's disease (ADMET2 trial)

IF 3.6 3区医学 Q2 GERIATRICS & GERONTOLOGY

International Journal of Geriatric Psychiatry Pub Date : 2024-06-10 DOI:10.1002/gps.6108

Lijuan Zeng, Jamie Perin, Alden L. Gross, David Shade, Krista L. Lanctôt, Alan J. Lerner, Jacobo E. Mintzer, Olga Brawman-Mintzer, Prasad R. Padala, Christopher H. van Dyck, Anton P. Porsteinsson, Suzanne Craft, Allan Levey, Nathan Herrmann, Paul B. Rosenberg

{"title":"Adverse effects of methylphenidate for apathy in patients with Alzheimer's disease (ADMET2 trial)","authors":"Lijuan Zeng, Jamie Perin, Alden L. Gross, David Shade, Krista L. Lanctôt, Alan J. Lerner, Jacobo E. Mintzer, Olga Brawman-Mintzer, Prasad R. Padala, Christopher H. van Dyck, Anton P. Porsteinsson, Suzanne Craft, Allan Levey, Nathan Herrmann, Paul B. Rosenberg","doi":"10.1002/gps.6108","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objectives</h3>\n \n <p>To examine clinically important adverse events (AEs) associated with methylphenidate (MPH) treatment of apathy in Alzheimer's Disease (AD) versus placebo, including weight loss, vital signs, falls, and insomnia.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>The Apathy in Dementia Methylphenidate Trial 2 (ADMET2) trial was a multicenter randomized, placebo-controlled trial of MPH to treat apathy in individuals with apathy and AD. Participants in ADMET2 had vital signs and weight measured at monthly visits through 6 months. AEs, including insomnia, falls, and cardiovascular events, were reported at every visit by participants and families using a symptom checklist.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The study included 98 participants in the MPH group and 101 in the placebo group. Participants in the MPH group experienced greater weight loss on average than the placebo through the 6-month follow-up, with a difference in change between MPH and placebo of 2.8 lb (95% confidence interval, CI: 0.7, 4.9 lb). No treatment group differences in change during the trial were found in systolic and diastolic blood pressure. More participants in the MPH group reported falls during the follow-up, 10 versus 6 in MPH and placebo groups, respectively. No differences in post-baseline insomnia were observed between the treatment groups. No participants reported instances of myocardial infarction, congestive heart failure, arrhythmia, stroke, or cardiomyopathy throughout the study period.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>MPH use in AD patients for treating apathy is relatively safe, particularly notable given the many medical comorbidities in this population. There was a statistically significant but modest weight loss associated with MPH use, and clinicians are thus advised to monitor weight during MPH treatment.</p>\n </section>\n </div>","PeriodicalId":14060,"journal":{"name":"International Journal of Geriatric Psychiatry","volume":"39 6","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Geriatric Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/gps.6108","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives

To examine clinically important adverse events (AEs) associated with methylphenidate (MPH) treatment of apathy in Alzheimer's Disease (AD) versus placebo, including weight loss, vital signs, falls, and insomnia.

Methods

The Apathy in Dementia Methylphenidate Trial 2 (ADMET2) trial was a multicenter randomized, placebo-controlled trial of MPH to treat apathy in individuals with apathy and AD. Participants in ADMET2 had vital signs and weight measured at monthly visits through 6 months. AEs, including insomnia, falls, and cardiovascular events, were reported at every visit by participants and families using a symptom checklist.

Results

The study included 98 participants in the MPH group and 101 in the placebo group. Participants in the MPH group experienced greater weight loss on average than the placebo through the 6-month follow-up, with a difference in change between MPH and placebo of 2.8 lb (95% confidence interval, CI: 0.7, 4.9 lb). No treatment group differences in change during the trial were found in systolic and diastolic blood pressure. More participants in the MPH group reported falls during the follow-up, 10 versus 6 in MPH and placebo groups, respectively. No differences in post-baseline insomnia were observed between the treatment groups. No participants reported instances of myocardial infarction, congestive heart failure, arrhythmia, stroke, or cardiomyopathy throughout the study period.

Conclusions

MPH use in AD patients for treating apathy is relatively safe, particularly notable given the many medical comorbidities in this population. There was a statistically significant but modest weight loss associated with MPH use, and clinicians are thus advised to monitor weight during MPH treatment.

查看原文本刊更多论文

哌醋甲酯治疗阿尔茨海默病患者冷漠症的不良反应（ADMET2 试验）。

研究目的研究与安慰剂相比，哌醋甲酯（MPH）治疗阿尔茨海默病（AD）患者淡漠症的临床重要不良事件（AEs），包括体重下降、生命体征、跌倒和失眠：痴呆症中的淡漠哌甲酯试验 2（ADMET2）是一项多中心随机安慰剂对照试验，采用 MPH 治疗患有淡漠症和老年痴呆症的患者的淡漠症。ADMET2试验的参与者在6个月内每月接受一次生命体征和体重测量。参与者及其家属在每次就诊时都会使用症状检查表报告不良反应，包括失眠、跌倒和心血管事件：该研究包括 98 名 MPH 组参与者和 101 名安慰剂组参与者。在6个月的随访中，MPH组参与者的体重平均下降幅度大于安慰剂组，MPH组与安慰剂组之间的变化差异为2.8磅（95%置信区间：0.7-4.9磅）。试验期间，收缩压和舒张压的变化没有发现治疗组间的差异。在随访期间，MPH 组有更多的参与者报告跌倒，MPH 组和安慰剂组分别为 10 人和 6 人。治疗组之间在基线后失眠方面没有差异。在整个研究期间，没有参与者报告发生心肌梗塞、充血性心力衰竭、心律失常、中风或心肌病：结论：在AD患者中使用MPH治疗淡漠是相对安全的，特别是考虑到这一人群有许多合并症。据统计，使用 MPH 会导致体重减轻，但幅度不大，因此建议临床医生在使用 MPH 治疗期间监测体重。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

International Journal of Geriatric Psychiatry 医学-精神病学

CiteScore

6.10

自引率

2.50%

发文量

168

审稿时长

4-8 weeks

期刊介绍： The rapidly increasing world population of aged people has led to a growing need to focus attention on the problems of mental disorder in late life. The aim of the Journal is to communicate the results of original research in the causes, treatment and care of all forms of mental disorder which affect the elderly. The Journal is of interest to psychiatrists, psychologists, social scientists, nurses and others engaged in therapeutic professions, together with general neurobiological researchers. The Journal provides an international perspective on the important issue of geriatric psychiatry, and contributions are published from countries throughout the world. Topics covered include epidemiology of mental disorders in old age, clinical aetiological research, post-mortem pathological and neurochemical studies, treatment trials and evaluation of geriatric psychiatry services.