Clinical trial of vestibular therapy to reduce falls in patients with Alzheimer's disease

前庭疗法减少阿尔茨海默病患者跌倒的临床试验

• 批准号: 10611308
• 负责人: Yuri Agrawal
• 金额: $ 51.49万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10611308
• 关键词: Adherence; Adult; Adverse event; Affect; Age; Alzheimer' s Disease; Alzheimer' s disease patient; Blinded; Brain; Calendar; Caregivers; Clinical Research; Clinical Trials; Cognition; Cognitive; Compensation; Data; Effectiveness; Elderly; Enrollment; Equilibrium; Event; Exercise; Fostering; Gait; Goals; Head; High Prevalence; Hospitalization; Impaired cognition; Impairment; Infrastructure; Injury; Institutionalization; Intervention; Labyrinth; Maps; Measures; Mediating; Memory; Morbidity - disease rate; Multicenter Trials; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physiology; Play; Positioning Attribute; Prevalence; Public Health; Randomized; Randomized, Controlled Trials; Rehabilitation therapy; Research; Research Assistant; Resources; Risk; Risk Factors; Role; Rotation; Sampling; Sensory; System; Testing; Vestibular loss; Work; active control; clinical practice; clinically significant; cognitive skill; comorbidity; comparative efficacy; design; effective intervention; experience; fall risk; falls; follow-up; improved; innovation; mortality; novel; pilot trial; prospective; randomized, clinical trials; recruit; treatment center

Project summary Patients with Alzheimer’s disease (AD) are known to have greater balance and gait impairment and double the rate of falls relative to healthy older adults (60-70% vs ~30%). Currently, few effective interventions exist to manage and mitigate falls in AD, and unfortunately, falls continue to be one of the primary drivers of morbidity, institutionalization, and mortality among AD patients. Recent studies have shown that AD patients have a two-fold higher prevalence of vestibular impairment (~50%) relative to age-matched controls (~25% prevalence). Additionally, in pilot data from an ongoing observational study, we have shown that vestibular loss is associated with an increased rate of falls in AD patients. Vestibular therapy (VT) is a well-established treatment for vestibular loss, and consists of physical therapy-based exercises designed to foster compensation for reduced vestibular function. VT is effective in improving balance and reducing fall risk in cognitively-intact patients with vestibular impairment. However, whether VT could be effective in improving balance and reducing falls in AD patients with vestibular loss has never been explored. In this study, we propose a randomized controlled trial of VT in 100 patients with mild-moderate AD who have vestibular impairment. We will randomize patients 1:1 to a standard course of VT (1 session per week for 8 weeks) or to an active control matched for effort and duration. We will compare the efficacy of VT vs. active control primarily on 1-year incident fall rate. We will also investigate potential intermediate outcomes between VT and falls – specifically balance outcomes (a predicted target of VT) and spatial cognitive outcomes (a novel target of VT) – to understand potential mechanisms by which VT may influence fall rates. We hypothesize that VT will have preliminary efficacy in reducing 1-year incident fall rates relative to an active control intervention in a convenience sample of 100 patients with mild-moderate AD. We will also explore whether VT has preliminary efficacy in improving balance and cognition relative to the active control intervention. To accomplish the proposed study, we will recruit 100 patients from the Memory and Alzheimer’s Treatment Center, a well-established AD clinical research resource at Johns Hopkins. Falls are a disastrous outcome in patients with AD. If this pilot trial followed by a Phase III multi-center trial provide strong evidence for the benefit of VT in reducing falls, this low-risk intervention could be widely disseminated and implemented by an existing workforce and infrastructure, and produce substantial, sustained change in AD clinical practice.

项目摘要 已知阿尔茨海默病（AD）患者具有更大的平衡和步态障碍， 相对于健康的老年人，福尔斯的比率下降（60-70% vs ~30%）。目前，有效的干预措施很少。 管理和缓解AD中的福尔斯，不幸的是，福尔斯仍然是AD的主要驱动因素之一。 AD患者的发病率、住院率和死亡率。最近的研究表明，AD患者 与年龄匹配的对照组（~ 25%）相比， 患病率）。此外，在一项正在进行的观察性研究的试点数据中，我们已经表明，前庭 损失与AD患者中增加的福尔斯率有关。前庭治疗（VT）是一种公认的 治疗前庭损失，并包括物理治疗为基础的练习，旨在促进 对前庭功能下降的补偿。VT在改善平衡和降低跌倒风险方面是有效的， 认知功能完好的前庭损伤患者。然而，VT是否能有效改善 平衡和减少前庭丧失的AD患者的福尔斯还从未被探索过。本研究 我建议在100名患有前庭功能障碍的轻中度AD患者中进行VT的随机对照试验。 损伤我们将患者按1：1随机分配至标准VT疗程（每周1次，持续8周）或 到与努力和持续时间相匹配的主动控制。我们将比较VT与主动控制的疗效 主要是1年的事故下降率。我们还将研究VT和VT之间的潜在中间结果， 和福尔斯-特别是平衡结果（VT的预测目标）和空间认知结果（一种新的 VT的目标）-了解VT可能影响跌倒率的潜在机制。我们假设 VT在降低1年事故率方面相对于主动控制具有初步功效 在100例轻中度AD患者的便利样本中进行干预。我们还将探讨 相对于主动控制干预，VT在改善平衡和认知方面具有初步疗效。 为了完成这项研究，我们将招募100名来自记忆和阿尔茨海默氏症的患者。 治疗中心，约翰霍普金斯一个完善的AD临床研究资源。福尔斯是一个 AD患者的灾难性后果。如果这项试点试验随后进行III期多中心试验，则提供 强有力的证据表明VT在减少福尔斯方面的益处，这种低风险的干预措施可以广泛地 由现有的劳动力和基础设施传播和实施，并产生大量的， AD临床实践的持续变化。