. We are requesting an administrative supplement to expand participant recruitment and testing to the VA Northern California Healthcare System (VANCHCS) in Martinez. The supplement would reduce five potential risks to the long-term scientific impact of second generation California Cognitive Assessment Battery (CCAB-2) tests: ? Recruitment. Participant recruitment has been compromised by the establishment of a California-funded Alzheimer?s Disease Research Center at our original recruitment site. Expanding recruitment and testing to the VANCHCS will resolve this problem and increase participant diversity: there are more than 32,000 eligible older participants within the VANCHCS catchment who meet study inclusion criteria. ? Milestone completion. Our research plan calls for nearly 5,000 assessments over three years, with nearly 2,300 assessments planned in Phase II, year 1. This would require 9.1 assessments per day during year 1, i.e. approximately 20 hours of testing. The assistance of trained VA staff and the established VANCHCS? infrastructure will assist us in meeting these testing challenges. ? CCAB-2 compatibility with hospital data security protocols. In the original application, CCAB-2 testing was limited to NBS offices. The supplement will support the software development and testing needed to ensure that CCAB-2 tests function within secure healthcare IT networks with extensive data protection safeguards and HIPAA-compliant protocols. ? CCAB-2 usability and robustness. In the original application, CCAB-2 test administration was limited to NBS personnel. This administrative supplement will enable extensive field testing by VA scientists and clinicians to ensure CCAB-2 robustness and usability prior to commercial launch. ? Disseminating results. The extensive testing demands in the original application would limit NBS scientific outreach. The supplement will support VA scientists in publicizing CCAB-2 capabilities at conferences, Alzheimer?s Disease Centers, grand rounds, research labs, department colloquia, and in peer-reviewed publications.

Public Health Relevance

Alzheimer?s disease is a health care burden with enormous medical and personal cost that will affect an increasing number of Americans as the population ages. Cognitive testing plays a central role in identifying at-risk patients: declines in cognitive tests of memory and other mental functions can be detected long before the onset of dementia. Moreover, the success of clinical trials for new therapies designed to reverse Alzheimer?s pathology and slow cognitive decline depends on the sensitivity of the tests used to detect cognitive deterioration. The cognitive tests currently used are mostly ?paper-and-pencil? assessments that require manual administration. We propose to develop a set of innovative, computerized cognitive tests with greater sensitivity and reliability than manual tests, and demonstrate their increased sensitivity to cognitive decline by repeatedly testing a large group of older individuals, including some with increased genetic risk for Alzheimer?s disease.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
3R44AG062076-02S1
Application #
10039211
Study Section
Program Officer
Plude, Dana Jeffrey
Project Start
2019-12-01
Project End
2022-08-31
Budget Start
2020-02-15
Budget End
2020-08-31
Support Year
2
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Neurobehavioral Systems, Inc.
Department
Type
DUNS #
089606763
City
Albany
State
CA
Country
United States
Zip Code
94706