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DANA; A Tool to Detect Cognitive Changes in Pre-clinical and MCI Patients (Admin Supplement)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AG063635-02
Agency Tracking Number: R44AG063635
Amount: $2,262,228.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA18-591
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-03-15
Award End Date (Contract End Date): 2020-09-30
Small Business Information
Silver Spring, MD 20910-3937
United States
DUNS: 128374548
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (301) 495-0770
Business Contact
Phone: (301) 495-0770
Research Institution

Project Summary/Abstract
The goals of this proposed project are to develop the DANA app into a tool that can be
easily used remotely by COVID-19 patients after discharge from an Intensive Care Unit
(ICU) and to provide clinicians with meaningful data on the immediate and long term
effects of COVID-19 on a patient’s cognitive function. DANA will also help clinicians
optimize neurocognitive rehabilitation. DANA is an FDA-cleared neurocognitive
assessment tool that has been shown to be a valid and reliable method for screening
cognitive functioning and tracking changes in cognitive functioning over time.
Importantly, DANA can provide results virtually through a HIPAA-compliant portal, which
will protect the clinician and others from exposure to the patient.
The specific aims of the proposal are: (1) technical modifications and support of DANA
for in-home self-administration and remote monitoring of COVID-19 patients, and (2)
deploy and show efficacious use of DANA with recovering COVID-19 patients. These will
build on the specific aims of the current Phase II SBIR, which includes the same
longitudinal surveillance for participants either at-risk for Alzheimer’s or diagnosed with
Mild Cognitive Impairment (MCI).
Three control populations, composed of (1) hospitalized COVID-19 patients who do not
require ICU admission, (2) post-discharge ICU patients without COVID-19, and (3)
healthy participants from the Alzheimer’s Disease Center Registry. All participants will be
given DANA immediately before leaving the hospital to determine a baseline, then they
will administer the DANA tests to themselves while they convalesce in isolation.
Technical changes specific to the needs of COVID-19 patients will be made to the DANA
software in order to make DANA easier to use at home and provide optimal data to the
clinician.Project Narrative
As the number of those diagnosed with COVID-19 rises, evidence has emerged that it
may affect cognitive performance, and it is critical to learn more about this issue in order
to provide those patients with the best care. To fill that need, this project will provide data
on COVID-19 patients’ cognitive function and essential insight into the longitudinal
effects of COVID-19 on the brain. It will also optimize the DANA app for use by remote
COVID-19 patients, so that clinicians will have access to the best possible tool for
understanding their patients’ ongoing cognitive needs.

* Information listed above is at the time of submission. *

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