Notice of Intent to Publish a Notice of Funding Opportunity for Biomarkers of Cognitive Decline and Dementias of Aging in Individuals within the Autism Spectrum (U01 Clinical Trial Optional)
Notice Number:
NOT-AG-24-082

Key Dates

Release Date:
November 18, 2024
Estimated Publication Date of Notice of Funding Opportunity :
December 15, 2024
First Estimated Application Due Date:
February 15, 2025
Earliest Estimated Award Date:
September 01, 2025
Earliest Estimated Start Date:
September 01, 2025
Related Announcements

None

Issued by

National Institute on Aging (NIA)

Purpose

The National Institute on Aging intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to invite applications to conduct observational studies in individuals living with Autism Spectrum Disorders (ASD) along the lifespan. The overarching goal is to use deep phenotyping, including neuroimaging, molecular and other approaches, to discover and characterize biomarkers of neurodegeneration in this population, in relation with clinical manifestation of age-related decline in multiple cognitive domains. The project may also support evaluation of the performance of established dementia biomarkers in the context of ASD, or retrospective analysis of datasets aimed at the discovery of ASD-specific features of cognitive decline and neurodegeneration, as well as post-mortem studies to characterize markers of neurodegeneration and/or processes that contribute to neurodegeneration. Studies to develop and validate tools for comprehensive clinical characterization and/or functional assessment in this population are also invited.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The NOFO is expected to be published in December 2024 with an expected application due date in February 2025.

This NOFO will utilize the U01 activity code. Details of the planned NOFO are provided below.

Research Initiative Details

This NOFO will encourage rigorous and systematic observational studies along the lifespan of ASD individuals, to determine the occurrence of age-related neurodegeneration across the heterogeneities of the ASD spectrum, characterize the physiopathology and manifestation of Alzheimer's disease (AD) and AD-related dementias (ADRD) in ASD and, ultimately, develop precision-medicine strategies tailored to the special needs of this understudied population. It is expected that proposed studies pursue deep phenotyping of aging individuals across the ASD spectrum, along with the characterization/validation of existing biomarkers of age-related cognitive decline and/or dementia in this population, and/or the discovery of novel ones. This NOFO will accelerate collaborations between investigators with expertise in autism and those with expertise in aging and dementia, fostering interactions between established centers for neurodevelopmental research and centers studying age-related cognitive decline. Ultimately, this NOFO aims to establish a large cohort of individuals within the ASD spectrum through the collaborative efforts of multiple sites, the establishment of novel research programs that combine ASD and AD/ADRD expertise, as well as the development and dissemination of dedicated and harmonized protocols, to allow for statistically-powered and rigorous observational studies leading to the discovery and clinical validation of new and/or established biomarkers of age-related cognitive decline applicable to this population.

This NOFO will invite applications for research studies in living humans, or those using human bio specimen or existing data. Studies focusing on animal models will be considered not responsive. Studies should focus on aging individuals across the ASD spectrum. While approaches encompassing “aging along the lifespan” will be appropriate, studies limited to prenatal, perinatal, infants or early childhood will not be considered responsive. Additionally, although broad inclusion criteria will be valued, consistent with the current consensus for clinical diagnosis of ASD and acknowledging the heterogeneity of the autistic spectrum, studies focused on the impact of neurodevelopment on cognitive function, rather than aging-related neurodegenerative processes leading to cognitive decline, will not be considered responsive. Applications focusing on behavioral/psychiatric symptoms in aging individuals with ASD will be considered responsive, as long as the occurrence/exacerbation of such symptoms can be related to age-related cognitive decline and/or neurodegeneration, similar to the psychiatric manifestations observed in AD and ADRD, including PDD, LBD, and FTD. Non-responsive applications will not be reviewed for this NOFO.

Funding Information

Estimated Total Funding

NIA intends to commit up to $5,000,000 in total costs in fiscal year 2025. Future year amounts will depend on annual appropriations.

Expected Number of Awards

NIA intends to fund an estimate of 1-4 awards in fiscal year 2025.

Estimated Award Ceiling

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Primary Assistance Listing Number(s)

93.866

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Alessandra Rovescalli, Ph.D.
National Institute on Aging
Telephone: 301-215-0335
Email: rovescaa@mail.nih.gov