# Interactive Software for Assessing Meaningful Cognitive Function

> **NIH NIH R43** · ABILITY INTERACTIVE LLC · 2021 · $499,360

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10323851
- **Project number:** 1R43AG074740-01
- **Recipient organization:** ABILITY INTERACTIVE LLC
- **Principal Investigator:** John Eric Ferguson
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $499,360
- **Award type:** 1
- **Project period:** 2021-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323851

## Citation

> US National Institutes of Health, RePORTER application 10323851, Interactive Software for Assessing Meaningful Cognitive Function (1R43AG074740-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10323851. Licensed CC0.

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