Interactive Software for Assessing Meaningful Cognitive Function

用于评估有意义的认知功能的交互式软件

基本信息

批准号：
10323851
负责人：
John Eric Ferguson
金额：
$ 49.94万
依托单位：
ABILITY INTERACTIVE LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10323851
关键词：
Activities of Daily Living Address Adult Affect Age Alzheimer disease prevention Alzheimer&apos s Disease Alzheimer&apos s disease related dementia Assessment tool Categories Clinical Clinical Trials Cognition Cognitive Computer software Computers Dementia Development Devices Disease Progression Early Diagnosis Educational workshop Elderly Episodic memory Family Caregiver Feedback Future Goals Guidelines Healthcare Systems Individual Lead Learning Measures Monitor National Institute on Aging Outcome Measure Participant Pharmaceutical Preparations Phase Prevention Process Psychometrics Recommendation Sample Size Sampling Scanning Self Administration Semantics Small Business Innovation Research Grant Social Interaction Speech Symptoms Technology Testing Transact United States Food and Drug Administration Validation Validity and Reliability acceptability and feasibility aging population base clinical Diagnosis cognitive ability cognitive function computerized cost design digital disability executive function functional outcomes improved improved outcome instrumental activity of daily living mild cognitive impairment novel novel strategies processing speed programs prototype public health priorities simulation socioeconomics software development touchscreen user centered design

项目摘要

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.

项目概要阿尔茨海默病 (AD) 和 AD 相关痴呆 (ADRD) 与严重残疾相关受影响的个人、家庭护理人员和医疗保健人员失去独立性、负担和费用尽管人口老龄化迅速增长，AD 和轻度疾病的成本和后果也很高。认知障碍（MCI）、AD 和 MCI 临床试验基本上不成功，成本高昂，而且还没有能够证明具有临床意义的效果，例如延迟临床症状的发生或进展成功预防痴呆症的一个重要障碍是目前可用的结果。 MCI 临床试验中使用的措施无法检测到认知和功能的有意义的变化发生在 MCI 中，导致效应较小，需要大样本量进行临床试验。新的评估工具对具有临床意义的认知和功能的最早变化敏感迫切需要改变 MCI 临床试验并成功预防痴呆症。满足改进 MCI 临床试验结果测量的迫切需要，其中包括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、开发和测试一种新颖的计算机化评估工具，该工具结合了临床有意义的认知和功能，以改善 MCI 临床试验的结果测量。 “IADL 任务中的功能”(C-FIT) 评估工具将很容易通过语音或触摸屏进行自我管理输入；可靠且可重复；并且能够有效地检测早期且有意义的功能性变化 C-FIT 评估工具的目标是改善患有 MCI 的老年人的早期发现。在 MCI 临床试验中认知和功能的改变在这个 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：C-FIT 评估工具的初步测试目标 3：展示 C-FIT 评估工具的初始可靠性和有效性。为了实现这些目标，我们将设计一种新颖的计算机化评估来评估关键认知我们将在 10 名成年人中测试 C-FIT 评估工具。 65 岁或以上：5 名认知健康的人和 5 名临床诊断为 MCI 的人。以用户为中心的设计流程，并利用参与者的反馈迭代改进 C-FIT 评估。将对 30 名 65 岁或以上的成年人进行心理传导测试：其中 15 名有认知能力健康且临床诊断为 MCI 的 15 名参与者将完成重测可靠性评估。 C-FIT 评估两次，间隔两周，每个时间点的分数将使用班级内进行比较。为了评估同时有效性，参与者将完成经过验证的认知和相关系数。 MCI 临床试验中使用的功能测试分数将使用皮尔逊相关系数进行比较。