R01AG077677
Project Grant
Overview
Grant Description
Innovative Deep Phenotyping of African Americans at Risk for Alzheimer's Disease - Project Summary
A critical gap in Alzheimer's Disease (AD) and Alzheimer's Disease Related Disorders (ADRD) clinical research is the vast under-representation of Black/African American (AA) older adults. It is well-documented that AD+ADRD is more prevalent in AA individuals relative to white individuals of European ancestry. Early detection of AD+ADRD is critical for clinical trials aiming to develop optimal therapeutics. Without adequate representation of AA in cognitive and biomarker studies examining the earliest changes in AD+ADRD, the diagnostic, prognostic, and clinical utility of promising biomarkers and their effects on cognition cannot be established.
Therefore, there is a pressing need to include and deeply phenotype AAs using novel cognitive and biomarker assessments that consider the multiple co-morbidities identified in this population. Study location has been identified as one of the most prevalent enrollment barriers for AA older adults. This current research proposal leverages our vast expertise in conducting home-based assessment to evaluate clinical and neuropsychological status with equipment that we place within the home. Importantly, we will provide door-to-door transportation for MRI and amyloid PET imaging studies that we have successfully employed to recruit and retain culturally diverse older adults including AA, with and without cognitive impairment, into biomarker studies. This will facilitate a user-friendly and effective approach that supports the engagement of AA older adults.
Other important and innovative aspects of our proposed study include:
A) The use of our novel cognitive challenge tests (CCTs) that employ sensitive and specific cognitive assessment paradigms that have been associated with biomarkers of AD and neurodegeneration, and have been validated for use in AA older adults with and without mild cognitive impairment (MCI).
B) Use of state-of-the-science plasma-based markers of AD and neurodegeneration that leverage extremely sensitive SIMOA technology.
C) We will uniquely relate our novel CCTs at baseline and longitudinally to changes over time in serially collected plasma biomarkers (e.g., P-TAU181, P-TAU217, NFL, GFAP).
D) Comparison of plasma markers of AD and neurodegeneration with amyloid PET imaging and extra-cellular free water diffusion, as well as neurodegenerative changes on MRI.
E) Accounting for the comorbidity of common chronic conditions in the AA population, we will obtain sensitive measures of cerebrovascular disease, inflammation, diabetes and metabolic risk, as well as chronic kidney disease.
F) Structural and social determinants of health will also be assessed.
The deep phenotyping of 270 non-Hispanic AA older adults in the proposed research study and our resource sharing plan will accelerate efforts to gain critically needed knowledge of AD+ADRD in a seriously underrepresented AA group. The data obtained will promote the reproducibility of this work in extant databases that include AA and can facilitate comparison of findings with non-AA samples. This important cohort will continue to be followed throughout the funding period and beyond.
A critical gap in Alzheimer's Disease (AD) and Alzheimer's Disease Related Disorders (ADRD) clinical research is the vast under-representation of Black/African American (AA) older adults. It is well-documented that AD+ADRD is more prevalent in AA individuals relative to white individuals of European ancestry. Early detection of AD+ADRD is critical for clinical trials aiming to develop optimal therapeutics. Without adequate representation of AA in cognitive and biomarker studies examining the earliest changes in AD+ADRD, the diagnostic, prognostic, and clinical utility of promising biomarkers and their effects on cognition cannot be established.
Therefore, there is a pressing need to include and deeply phenotype AAs using novel cognitive and biomarker assessments that consider the multiple co-morbidities identified in this population. Study location has been identified as one of the most prevalent enrollment barriers for AA older adults. This current research proposal leverages our vast expertise in conducting home-based assessment to evaluate clinical and neuropsychological status with equipment that we place within the home. Importantly, we will provide door-to-door transportation for MRI and amyloid PET imaging studies that we have successfully employed to recruit and retain culturally diverse older adults including AA, with and without cognitive impairment, into biomarker studies. This will facilitate a user-friendly and effective approach that supports the engagement of AA older adults.
Other important and innovative aspects of our proposed study include:
A) The use of our novel cognitive challenge tests (CCTs) that employ sensitive and specific cognitive assessment paradigms that have been associated with biomarkers of AD and neurodegeneration, and have been validated for use in AA older adults with and without mild cognitive impairment (MCI).
B) Use of state-of-the-science plasma-based markers of AD and neurodegeneration that leverage extremely sensitive SIMOA technology.
C) We will uniquely relate our novel CCTs at baseline and longitudinally to changes over time in serially collected plasma biomarkers (e.g., P-TAU181, P-TAU217, NFL, GFAP).
D) Comparison of plasma markers of AD and neurodegeneration with amyloid PET imaging and extra-cellular free water diffusion, as well as neurodegenerative changes on MRI.
E) Accounting for the comorbidity of common chronic conditions in the AA population, we will obtain sensitive measures of cerebrovascular disease, inflammation, diabetes and metabolic risk, as well as chronic kidney disease.
F) Structural and social determinants of health will also be assessed.
The deep phenotyping of 270 non-Hispanic AA older adults in the proposed research study and our resource sharing plan will accelerate efforts to gain critically needed knowledge of AD+ADRD in a seriously underrepresented AA group. The data obtained will promote the reproducibility of this work in extant databases that include AA and can facilitate comparison of findings with non-AA samples. This important cohort will continue to be followed throughout the funding period and beyond.
Awardee
Funding Goals
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.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Miami,
Florida
331361409
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 215% from $1,414,551 to $4,456,098.
University Of Miami was awarded
Innovative Deep Phenotyping of African Americans for AD+ADRD
Project Grant R01AG077677
worth $4,456,098
from National Institute on Aging in June 2023 with work to be completed primarily in Miami Florida United States.
The grant
has a duration of 4 years 8 months and
was awarded through assistance program 93.866 Aging Research.
The Project Grant was awarded through grant opportunity Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 6/20/25
Period of Performance
6/1/23
Start Date
2/29/28
End Date
Funding Split
$4.5M
Federal Obligation
$0.0
Non-Federal Obligation
$4.5M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01AG077677
Additional Detail
Award ID FAIN
R01AG077677
SAI Number
R01AG077677-2330622314
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
F8THLJQSAF93
Awardee CAGE
9B962
Performance District
FL-26
Senators
Marco Rubio
Rick Scott
Rick Scott
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,414,551 | 100% |
Modified: 6/20/25