Interactive Software for Assessing Meaningful Cognitive Function
Award last edited on: 2/28/2022

Sponsored Program
Awarding Agency
Total Award Amount
Award Phase
Solicitation Topic Code
Principal Investigator
John Eric Ferguson

Company Information

Ability Interactive LLC (AKA:

3625 Woodland Trail
Eagan, MN 55123
   (703) 517-2392
Location: Single
Congr. District: 02
County: Dakota

Phase I

Contract Number: 1R43AG074740-01
Start Date: 9/30/2021    Completed: 8/31/2022
Phase I year
Phase I Amount
Alzheimer's disease (AD) and AD-related dementias (ADRD) are associated with significant disabilityand loss of independence, burden, and costs to affected individuals, family caregivers, and health caresystems. Despite the rapidly growing aging population and the high cost and consequences of AD and mildcognitive impairment (MCI), AD and MCI clinical trials have been largely unsuccessful, costly, and have notbeen able to demonstrate clinically meaningful effects such as delaying the onset or progression of clinicalsymptoms. One significant barrier to successful dementia prevention is that currently available outcomemeasures used in MCI clinical trials are unable to detect meaningful changes in cognition and function thatoccur in MCI, resulting in small effect sizes that require large sample sizes for clinical trials. Development ofnew assessment tools that are sensitive to the earliest changes in clinically meaningful cognition and functionare 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 incorporateFood and Drug Administration (FDA) recommendations and National Institute on Aging (NIA) strategicpriorities, we will design, develop, and test a novel computerized assessment tool that combines clinicallymeaningful cognition and function to improve outcome measures in MCI clinical trials. The "Cognition andFunction in an IADL Task" (C-FIT) Assessment Tool will be easy to self-administer via speech or touchscreeninput; reliable and repeatable; and effective in detecting early and meaningful cognitive and functional changesin older adults with MCI. The goal of the C-FIT assessment tool is to improve early detection of meaningfulchange 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 cognitiveand functional domains that are most sensitive to MCI. We will test the C-FIT assessment tool with 10 adultsages 65 or older: 5 who are cognitively healthy and 5 who have a clinical diagnosis of MCI. We will utilize auser-centered design process and iteratively improve the C-FIT assessment using participant feedback. Wewill conduct psychometric testing with a new sample of 30 adults ages 65 or older: 15 who are cognitivelyhealthy and 15 who have a clinical diagnosis of MCI. To assess test-retest reliability, participants will completethe C-FIT assessment twice, two weeks apart. Scores at each timepoint will be compared using intraclasscorrelation coefficients. To assess concurrent validity, participants will complete validated cognitive andfunctional tests used in MCI clinical trials. Scores will be compared using Pearson correlation coefficients. PROJECT NARRATIVE The 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. Activities of Daily Living ; Activities of everyday life ; daily living functionality ; functional ability ; functional capacity ; Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Age ; ages ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Alzheimer's Disease ; AD dementia ; Alzheimer ; Alzheimer Type Dementia ; Alzheimer disease ; Alzheimer sclerosis ; Alzheimer syndrome ; Alzheimer's ; Alzheimer's disease dementia ; Alzheimers Dementia ; Alzheimers disease ; Primary Senile Degenerative Dementia ; dementia of the Alzheimer type ; primary degenerative dementia ; senile dementia of the Alzheimer type ; Clinical Trials ; Cognition ; Computers ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Feedback ; Future ; Goals ; Healthcare Systems ; Health Care Systems ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Learning ; Psychometrics ; Recommendation ; Validity and Reliability ; Self Administration ; Self-Administered ; Semantics ; Social Interaction ; Computer software ; Software ; Speech ; Technology ; Testing ; United States Food and Drug Administration ; Food and Drug Administration ; USFDA ; Measures ; Family Caregiver ; Family Care Giver ; Outcome Measure ; Guidelines ; base ; improved ; Clinical ; Phase ; disability ; Individual ; Educational workshop ; Workshop ; Sample Size ; Disease Progression ; clinical Diagnosis ; programs ; cognitive function ; Scanning ; Amentia ; Dementia ; processing speed ; Episodic memory ; early detection ; Early Diagnosis ; Transact ; simulation ; novel ; Participant ; Categories ; Prevention ; Devices ; Sampling ; develop software ; developing computer software ; software development ; executive control ; executive function ; IADL ; instrumental activity of daily living ; Address ; Symptoms ; Cognitive ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Monitor ; Process ; socioeconomics ; socio-economic ; socio-economically ; socioeconomically ; Development ; developmental ; National Institute on Aging ; National Institute of Aging ; cost ; digital ; computerized ; design ; designing ; touchscreen ; touch panel ; touch screen ; touch screen panel ; touchscreen panel ; novel strategies ; new approaches ; novel approaches ; novel strategy ; functional outcomes ; user centered design ; Alzheimer disease prevention ; AD prevention ; Alzheimer prevention ; prototype ; aging population ; aged population ; population aging ; public health priorities ; mild cognitive impairment ; mild cognitive disorder ; cognitive ability ; Assessment tool ; Assessment instrument ; improved outcome ; Alzheimer's disease related dementia ; AD related dementia ; ADRD ; Alzheimer related dementia ; acceptability and feasibility ;

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
Phase II Amount