Notice Number: NOT-AG-18-047
Release Date: November 20, 2018
NOT-AG-22-007 - Notice to Expire NOSIs to PAR-19-070, "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)"
NOT-AG-22-006 - Notice to Expire NOSIs to PAR-19-070, "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)"PAR-19-070
National Institute on Aging (NIA)
This Notice of information specifies a high-priority topic of interest for PAR-19-070 "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)" and PAR-19-071 "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Not Allowed)".
Health Disparities and Alzheimer's Disease
Recent recommendations for AD research from the National Alzheimer’s Project Act, the 2012 Alzheimer’s Disease Research Summit, the health disparities session of the 2013 Alzheimer’s Disease and Related Dementias Meeting, and the 2015 Alzheimer’s Disease Research Summit have emphasized the need to diversify research cohorts and improve methods and tools for conducting health disparities research related to AD. It has been recommended that projects are needed that increase enrollment of underrepresented populations, expand the use of existing cohorts, and create robust estimates of AD in diverse populations. Improvements are also needed in research tools, research methods, and design and recruitment practices.
A limited number of studies sufficiently assess health disparities in AD and even fewer in non-AD dementias. Separate cohorts report differing results, and most studies fail to be powered with sufficient numbers of representative demographic populations to show interactions. The number of longitudinal studies in underrepresented populations is decreasing. Studies that established the current estimates of AD prevalence are cross-sectional measurements at best and cohorts are challenged in longitudinal follow-up.
There is a need to broaden the scope and improve the rigor of scientific investigations of AD that consider health disparities. Race, ethnicity, socioeconomic status, and sex/gender may be multifactorial in their influence on AD and cognitive impairment and decline. Studies incorporating geographical, neighborhood, education, environmental, biological, social, behavioral, lifestyle and genetic factors need to be conducted with study populations that have robust demographic diversity. Also, studies that investigate determinants of population-level differences in AD should be designed.
When cohorts are diverse, new mechanisms that link environmental, sociocultural, behavioral and biological factors can be identified. Health disparities populations are defined by Public Law 106-525, Minority Health and Health Disparities Research and Education Act of 2000 and include the following populations:
American Indians/Alaskan Natives
Native Hawaiians and Other Pacific Islanders
Additional Populations may include:
Socioeconomically Disadvantaged Populations
Sex and Gender Minorities
This high-priority topic encourages applications that examine mediators of disparities in Alzheimer’s disease, using diverse cohorts of subjects with, but not limited to, the following characteristics:
Alzheimer’s disease and related dementias risk and diversity. Robust estimates of AD and related dementias are needed in diverse populations. Research is encouraged on the recruitment of cohorts that include diverse subjects to conduct standardized diagnostic evaluations. Research is needed to understand the demographic diversity of dementia risk and whether this risk can attribute to factors of health disparities.
Effect of educational attainment on dementia risk. While the large growth in the number of older adults in the coming decades will lead to an increase in dementia cases in countries around the world, a number of recent studies have suggested that the age-specific risk of dementia has actually decreased in some high-income countries over the last 20 years, possibly due to increasing levels of education. Research is needed to understand the mechanisms by which education contributes to declines in the age-specific risk of dementia, whether this trend will continue in the face of rising levels of obesity and diabetes, and whether there has been a similar or opposite trend in demographically diversity population.
Diversity and cognitive change over time. Multiple factors, in addition to race/ethnicity, need to be considered when studying the status of cognitive change over time. Analyses of the relationship of race, education, comorbidities, geographic location, and additional demographic diversity on dementia risk and cognitive resilience using existing data are encouraged.
Diagnosis and assessment procedures. Procedures for cognitive assessment need to be evaluated in concert with environmental, sociocultural, behavioral and biological factors. Research is encouraged on disparities in cognitive testing procedures, clinic participation rates, and validity of assessment procedures.
Neuroimaging, neuropathology and the biology of AD. Neuroimaging techniques and post mortem evaluations need to be increased in underrepresented populations. Research studies are encouraged focusing on the analysis of the multifactorial effects of factors and demographic diversity on the biology of AD and neuroimaging outcomes as such research may highlight the effect some risk factors have on the development of AD. This includes 1) determinants of brain anatomy and cognitive ability; 2) neuropathological identification of disease; and 3) identification of biologic markers.
Analyses of pathways that create and sustain AD disparities. Investigators are encouraged to focus on biological indicators to link with behavioral, sociocultural or environmental factors to understand disparities in AD. Biological indicators of interest include, but are not limited to, physiological indicators, genetic stability, cellular function and communication, mitochondrial dysfunction, cellular senescence, cellular stress response, intercellular communication, epigenetic alteration and telomere attrition.
Strategies for recruitment and retention. Using novel recruitment strategies (including those described in Summit recommendations), research is also encouraged on overcoming logistical barriers specific to AD and related dementia research and disparities in clinical research and clinical trial participation. For further information of this need, see “National Strategy for Recruitment and Participation in Alzheimer's Disease Clinical Research” at: https://www.nia.nih.gov/research/recruitment-strategy.
Applications that either propose clinical trials or do not propose clinical trials may be considered a high priority.
Please direct all inquiries to:
Cerise L. Elliott, Ph.D
National Institute on Aging (NIA)
Division of Neuroscience
Frank Bandiera, Ph.D.
National Institute on Aging (NIA)
Division of Behavioral and Social Research