ABILITY INTERACTIVE LLC — Department of Health and Human Services SBIR Phase I: NIA

Description

PROJECT SUMMARYAlzheimer’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.PROJECT NARRATIVEThe prevention of Alzheimer’s disease (AD) and AD-related dementias (ADRD) is a top public health priority due to the devastating socioeconomic consequences of AD/ADRD, and yet clinical trials for dementia prevention have been costly and largely unsuccessful. New assessment tools that are sensitive to the earliest changes in clinically meaningful cognition and function in mild cognitive impairment (MCI) can address a critical unmet need in clinical trials for dementia prevention. The proposed project will design, develop, and test the “Cognition and Function in an IADL Task” (C-FIT) Assessment Tool to improve early detection of meaningful cognitive and functional changes in MCI Clinical Trials.