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.

项目概要 众所周知，阿尔茨海默病 (AD) 患者的平衡能力和步态障碍更严重，并且双倍 相对于健康老年人的跌倒率（60-70% vs ~30%）。目前有效的干预措施还很少 存在用于管理和减轻 AD 跌倒的风险，不幸的是，跌倒仍然是 AD 的主要驱动因素之一 AD 患者的发病率、住院治疗和死亡率。最近的研究表明，AD 患者 与年龄匹配的对照组（约 25%）相比，前庭障碍患病率（约 50%）高出两倍 流行率）。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 患者跌倒率增加有关。前庭疗法（VT）是一种成熟的治疗方法 治疗前庭丧失，包括基于物理治疗的练习，旨在促进 补偿前庭功能下降。 VT 可有效改善平衡并降低跌倒风险 认知功能完整且前庭功能障碍的患者。然而，VT是否能有效改善 平衡和减少前庭丧失的 AD 患者跌倒的情况尚未被探索过。在这项研究中，我们 提议对 100 名患有前庭功能障碍的轻中度 AD 患者进行 VT 随机对照试验 损害。我们将按照 1:1 的比例将患者随机分配至标准 VT 疗程（每周 1 次，持续 8 周）或 与努力和持续时间相匹配的主动控制。我们将比较 VT 与主动控制的功效 主要是一年的事故下降率。我们还将研究 VT 之间潜在的中间结果 和跌倒——特别是平衡结果（VT 的预测目标）和空间认知结果（一种新颖的 VT 目标）——了解 VT 影响跌倒率的潜在机制。我们假设 相对于主动对照，VT 将在降低 1 年事故下降率方面具有初步功效 对 100 名轻度至中度 AD 患者的方便样本进行干预。我们还将探讨是否 VT相对主动控制干预在改善平衡和认知方面具有初步功效。 为了完成拟议的研究，我们将招募 100 名记忆和阿尔茨海默病患者 治疗中心是约翰霍普金斯大学完善的 AD 临床研究资源。瀑布是一个 AD 患者的灾难性后果。如果该试点试验随后进行 III 期多中心试验提供 有强有力的证据证明 VT 在减少跌倒方面的益处，这种低风险干预措施可以广泛应用 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。