R56AG074321

Detect-AD: Digital Evaluations and Technologies Enabling Clinical Translation for Alzheimer's Disease - Project Summary

This study (Detect-AD or Digital Evaluations and Technologies Enabling Clinical Translation for AD) aims to fundamentally improve the assessment of meaningful cognitive function in early pre- or Alzheimer's Disease (AD) using largely passive home-based digital assessment methods.

To achieve this goal, the approach will be tested in a prospective 36-month pre-clinical AD trial simulation using a current, shareable, technology agnostic, home-based assessment platform. This platform continuously generates passive and interactive sensor-derived digital biomarkers (DBs) and metrics of everyday cognition and function (Digital Indicators of Active Life Status or DIALS). The platform also allows for remote capture of conventional clinical assessments.

Participants with defined amyloid status (Ass-High vs. Ass-Low based on relative amyloid PET burdens) will be enrolled. Ass-High participants will progress as if they were receiving placebo, while those with lower Ass burdens will have less progression, simulating effective treatment. Participants will be asked to take a daily multivitamin as a study "drug" to mimic trial conditions.

The primary outcome will be the change in the DBs and composite DIALS from four key domains: mobility (gait speeds), cognition (computer usage), sleep (sleep times), and socialization (time out of home). The specific aims of this study are to:

1) Determine rates of progression of DBs (of mobility, cognition, sleep, and social engagement) individually and as an aggregate metric (the DIALS) in FDA Stage 1-3 AD (Ass-High vs. Ass-Low) participants, by establishing early base rates (first months of monitoring) of progression, and then longitudinal change.

2) Establish the utility of these DBs compared to conventional measures (CDR-SOB, ADCS-PACC) used in trials.

3) Investigate exploratory aims examining several high-value features of these DBs for application in trials and related studies, including:

3.1) Correlate DBs and DIALS with conventional imaging and blood-based biomarkers of inflammation, neurodegeneration, vascular risk or injury, and nutritional health.

3.2) Determine the change over time of embedded "cognitive clocks" (time to complete regular weekly online report queries and monthly cognitive tests).

3.3) Establish adverse event fluctuations over time (mood, illness, pain, ER, doctor, hospital visits, injury, non-study medication changes) via weekly remote assessment.

3.4) Assess the study partner's DBs change relative to the person with AD (mobility, sleep, social engagement).

The successful completion of this study will provide foundational validated DB and DIALS data, improving treatment response readout sensitivity and advancing AD clinical trial capability and capacity. The intent is to not only validate a single app or device but to advance ecologically valid multi-domain assessment, as well as an entire trials-environment specific, DB-facilitated protocol that could be adapted and shared for use by any clinical trial going forward.

Oregon Health & Science University

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Oregon United States

State-Wide

Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional) (PAR-19-070)

Amendment Since initial award the End Date has been extended from 06/30/23 to 06/30/25 and the total obligations have increased 140% from $1,474,986 to $3,543,037.