Interactive Software for Assessing Meaningful Cognitive Function

项目摘要 阿尔茨海默病（AD）和AD相关性痴呆（ADRD）与严重的残疾相关 以及受影响的个人、家庭照顾者和医疗保健的独立性、负担和成本的丧失 系统.尽管快速增长的老龄化人口以及AD和轻度AD的高成本和后果， 认知障碍（MCI）、AD和MCI的临床试验大多不成功，成本高， 能够证明具有临床意义的效果，如延迟临床疾病的发作或进展， 症状成功预防痴呆症的一个重要障碍是目前可用的结果 MCI临床试验中使用的测量方法无法检测到认知和功能的有意义的变化， 发生在MCI中，导致效应量小，需要大样本量进行临床试验。发展 对具有临床意义的认知和功能的最早变化敏感的新评估工具 迫切需要改变MCI临床试验，并成功预防痴呆症。 为了满足MCI临床试验改善结局指标的迫切需求， 美国食品药品监督管理局（FDA）的建议和国家老龄化研究所（NIA）的战略 优先事项，我们将设计，开发和测试一种新的计算机化评估工具，结合临床 有意义的认知和功能，以改善MCI临床试验中的结局指标。《认知与 IADL任务中的功能”（C-FIT）评估工具将易于通过语音或触摸屏进行自我管理 输入;可靠和可重复;有效检测早期和有意义的认知和功能变化 老年MCI患者中。C-FIT评估工具的目标是提高早期发现有意义的 MCI临床试验中认知和功能的变化。在SBIR第一阶段项目中，我们将实现三个目标： 目标1：设计和开发C-FIT评估工具。目标2：初步测试C-FIT评估工具。目标3： 证明C-FIT评估工具的初始可靠性和有效性。 为了实现这些目标，我们将设计一个新的计算机化评估，评估关键的认知能力， 和对MCI最敏感的功能结构域。我们将用10名成年人测试C-FIT评估工具 年龄65岁或以上：5名认知健康，5名临床诊断为MCI。我们将利用 以用户为中心的设计流程，并使用参与者反馈迭代改进C-FIT评估。我们 将对30名年龄在65岁或以上的成年人进行心理测试：15名认知能力较强的人， 健康人和15名临床诊断为MCI的人。为了评估重测信度，参与者将完成 C-FIT评估两次，间隔两周将使用组内比较每个时间点的评分 相关系数为了评估同时有效性，参与者将完成经验证的认知和 MCI临床试验中使用的功能测试。将使用Pearson相关系数比较评分。

PROJECT SUMMARY Alzheimer’s disease (AD) and AD-related dementias (ADRD) are associated with significant disability and loss of independence, burden, and costs to affected individuals, family caregivers, and health care systems. Despite the rapidly growing aging population and the high cost and consequences of AD and mild cognitive impairment (MCI), AD and MCI clinical trials have been largely unsuccessful, costly, and have not been able to demonstrate clinically meaningful effects such as delaying the onset or progression of clinical symptoms. One significant barrier to successful dementia prevention is that currently available outcome measures used in MCI clinical trials are unable to detect meaningful changes in cognition and function that occur in MCI, resulting in small effect sizes that require large sample sizes for clinical trials. Development of new assessment tools that are sensitive to the earliest changes in clinically meaningful cognition and function are desperately needed to transform MCI clinical trials and lead to successful dementia prevention. To address the critical need for improved outcome measures for MCI clinical trials that incorporate Food and Drug Administration (FDA) recommendations and National Institute on Aging (NIA) strategic priorities, we will design, develop, and test a novel computerized assessment tool that combines clinically meaningful cognition and function to improve outcome measures in MCI clinical trials. The “Cognition and Function in an IADL Task” (C-FIT) Assessment Tool will be easy to self-administer via speech or touchscreen input; reliable and repeatable; and effective in detecting early and meaningful cognitive and functional changes in older adults with MCI. The goal of the C-FIT assessment tool is to improve early detection of meaningful change in cognition and function in MCI clinical trials. In this SBIR Phase I project we will execute three aims: Aim 1: Design and develop the C-FIT assessment tool. Aim 2: Initial test of the C-FIT assessment tool. Aim 3: Demonstrate initial reliability and validity of the C-FIT assessment tool. To achieve these aims, we will design a novel computerized assessment that evaluates key cognitive and functional domains that are most sensitive to MCI. We will test the C-FIT assessment tool with 10 adults ages 65 or older: 5 who are cognitively healthy and 5 who have a clinical diagnosis of MCI. We will utilize a user-centered design process and iteratively improve the C-FIT assessment using participant feedback. We will conduct psychometric testing with a new sample of 30 adults ages 65 or older: 15 who are cognitively healthy and 15 who have a clinical diagnosis of MCI. To assess test-retest reliability, participants will complete the C-FIT assessment twice, two weeks apart. Scores at each timepoint will be compared using intraclass correlation coefficients. To assess concurrent validity, participants will complete validated cognitive and functional tests used in MCI clinical trials. Scores will be compared using Pearson correlation coefficients.