SBIR-STTR Award

DANA: a Tool to Detect Cognitive Changes in Pre-Clinical and MCI Patients
Award last edited on: 2/2/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$2,553,021
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
Corinna E Lathan

Company Information

AnthroTronix Inc (AKA: ATinc)

8403 Colesville Road Suite 1100
Silver Spring, MD 20910
   (301) 495-0770
   info@atinc.com
   www.anthrotronix.com
Location: Single
Congr. District: 08
County: Montgomery

Phase I

Contract Number: 1R44AG063635-01
Start Date: 7/1/2019    Completed: 12/31/2019
Phase I year
2019
Phase I Amount
$290,793
The goal of this proposed two phase project is to develop the Digital Automated Neurobehavioral Assessment (DANA) app into a tool that can be easily used by patients with Mild Cognitive Impairment (MCI) and Alzheimer’s disease (AD) and can provide clinicians with meaningful data in the tracking and diagnosis of these conditions. DANA is an FDA-cleared neurocognitive assessment tool that has been previously used with similar populations and has been shown to be a valid and reliable method for screening cognitive functioning and tracking changes in cognitive functioning over time. The specific aims of the proposal are: in Phase I (1) Determine technical feasibility and diagnostic accuracy of high-frequency cognitive testing with DANA; in Phase II (2) Technical development of DANA for in-home use; and (3) Establish predictive validity of DANA for the early detection of Alzheimer’s disease. In Phase I, this project will implement a pilot study. MCI patients and normal controls will take DANA both in-clinic and at home in order to examine the feasibility of this population using DANA in the home and DANA’s ability to discriminate between healthy and impaired users. In Phase II, this project will build on the results of Phase I to technically refine the DANA tool to better fit the needs of MCI patients. The refined app will be deployed in an experiment, involving MCI patients and normal controls, that will establish the predictive validity of DANA for the early detection of Alzheimer’s disease.

Public Health Relevance Statement:
Project Narrative Tracking the progression of Alzheimer’s disease is central to planning and implementing care for sufferers of the disease, and current methods fall short in providing the quality and depth of data needed to provide the best treatment. This project will fill this critical gap through the development of a tool built from the existing Digital Automated Neurobehavioral Assessment (DANA) app that can collect data at regular intervals via technology tailored towards a cognitively impaired user. This new tool will also help health care providers discriminate between healthy and impaired patients.

NIH Spending Category:
Acquired Cognitive Impairment; Aging; Alzheimer's Disease; Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD); Basic Behavioral and Social Science; Behavioral and Social Science; Brain Disorders; Clinical Research; Dementia; Mental Health; Neurodegenerative; Neurosciences; Prevention

Project Terms:
Achievement; Alzheimer disease detection; Alzheimer's Disease; Assessment tool; Award; Biological Markers; Boston; care providers; Caring; Clinic; Cognitive; cognitive change; cognitive function; cognitive testing; Collaborations; commercialization; Data; Department of Defense; Development; Diagnosis; Diagnostic; diagnostic accuracy; digital; Disease; Doctor of Philosophy; Early Diagnosis; Elderly; Engineering; Ensure; experimental group; experimental study; falls; Feedback; Frequencies; Goals; Health Personnel; Home environment; Impaired cognition; Impairment; improved; insight; Lead; Medical; Methods; mild cognitive impairment; Mind; neurobehavioral; Neurocognitive; neuroimaging; Notification; Outcome; Outcome Measure; Paper; Participant; Patients; Pattern; Performance; Phase; Pilot Projects; Population; pre-clinical; predictive modeling; Principal Investigator; Protocol Compliance; research and development; Sampling; screening; Self Administration; Small Business Innovation Research Grant; Technology; temporal measurement; Testing; Time; tool; Universities; usability; Variant; Visit; Woman

Phase II

Contract Number: 4R44AG063635-02
Start Date: 7/1/2019    Completed: 1/31/2022
Phase II year
2020
Phase II Amount
$2,262,228
The goal of this proposed two phase project is to develop the Digital Automated Neurobehavioral Assessment (DANA) app into a tool that can be easily used by patients with Mild Cognitive Impairment (MCI) and Alzheimer’s disease (AD) and can provide clinicians with meaningful data in the tracking and diagnosis of these conditions. DANA is an FDA-cleared neurocognitive assessment tool that has been previously used with similar populations and has been shown to be a valid and reliable method for screening cognitive functioning and tracking changes in cognitive functioning over time. The specific aims of the proposal are: in Phase I (1) Determine technical feasibility and diagnostic accuracy of high-frequency cognitive testing with DANA; in Phase II (2) Technical development of DANA for in-home use; and (3) Establish predictive validity of DANA for the early detection of Alzheimer’s disease. In Phase I, this project will implement a pilot study. MCI patients and normal controls will take DANA both in-clinic and at home in order to examine the feasibility of this population using DANA in the home and DANA’s ability to discriminate between healthy and impaired users. In Phase II, this project will build on the results of Phase I to technically refine the DANA tool to better fit the needs of MCI patients. The refined app will be deployed in an experiment, involving MCI patients and normal controls, that will establish the predictive validity of DANA for the early detection of Alzheimer’s disease.

Public Health Relevance Statement:
Project Narrative Tracking the progression of Alzheimer’s disease is central to planning and implementing care for sufferers of the disease, and current methods fall short in providing the quality and depth of data needed to provide the best treatment. This project will fill this critical gap through the development of a tool built from the existing Digital Automated Neurobehavioral Assessment (DANA) app that can collect data at regular intervals via technology tailored towards a cognitively impaired user. This new tool will also help health care providers discriminate between healthy and impaired patients.

Project Terms:
Achievement; Alzheimer disease detection; Alzheimer's Disease; Assessment tool; Award; Biological Markers; Boston; care providers; Caring; Clinic; Cognitive; cognitive change; cognitive function; cognitive testing; Collaborations; commercialization; Data; Department of Defense; Development; Diagnosis; Diagnostic; diagnostic accuracy; digital; Disease; Doctor of Philosophy; Early Diagnosis; Elderly; Engineering; Ensure; experimental group; experimental study; falls; Feedback; Frequencies; Goals; Health Personnel; Home environment; Impaired cognition; Impairment; improved; insight; Lead; Medical; Methods; mild cognitive impairment; Mind; neurobehavioral; Neurocognitive; neuroimaging; Notification; Outcome; Outcome Measure; Paper; Participant; Patients; Pattern; Performance; Phase; Pilot Projects; Population; pre-clinical; predictive modeling; Principal Investigator; Protocol Compliance; research and development; Sampling; screening; Self Administration; Small Business Innovation Research Grant; Technology; temporal measurement; Testing; Time; tool; Universities; usability; Variant; Visit; Woman