Frequently Asked Questions About the Consortium for Neuroscience AD/ADRD in Low- and Middle-income Countries

What is the purpose of the Funding Opportunity Announcement?

The purpose of this notice of funding opportunity (NOFO) is to promote collaborative research programs to support innovative and sustainable Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) neuroscience research for experienced investigators in low- and middle-income countries (LMICs). These collaborative research programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience capacity and research, ultimately leading to prevention and mitigation strategies for AD/ADRD in LMICs.

This NOFO will support proposals submitted from LMIC institutions. LMIC scientists are expected to collaborate with scientists from the United States.

How do I know the income category for LMICs?

NIH uses the income categories as defined by the World Bank .

What is the U01 activity code?

U01 is a milestone-driven Research Project Cooperative Agreement. Milestones will be negotiated with the PI(s) prior to the award being issued and should be approved by the NIH staff.

Cooperative Agreement

• Facilitates NIA’s program staff involvement as Project Scientists
• Allows additional oversight of awarded grants (i.e., review of milestones)
• Promotes collaborative work among the awardees:
  • Awardees should plan and budget for travel to an annual meeting.
  • The annual meeting will provide a forum for investigators from all funded projects to discuss research updates, identify opportunities for synergy and collaboration (e.g., data harmonization, protocol optimization), and identify pertinent research challenges and solutions.

When are the applications due?

There are two receipt dates for this NOFO: November 07, 2024 and February 14, 2025. No late applications will be accepted. In general, investigators should try to submit their applications a few days prior to the deadline so that you can make changes if needed.

What is the maximum budget and how many projects will be funded?

NIA intends to commit $2.16 million in fiscal years 2025 and 2026 to fund five awards. Application budgets are limited to $400,000 in direct costs per year.

What are some examples of research areas of interest?

Investigators should propose studies that advance understanding of AD/ADRD neuroscience in LMICs. Although study designs will depend upon the specific goals of the project, all applications must clearly define the population(s) or sub-population(s) of interest and describe how investigators will ensure representation appropriate for future research goals. All studies must have a neuroscience focus.

Investigators are encouraged to submit a draft specific aims page and discuss with Dr. Ghaleh and Dr. Martin.

Research areas include, but are not limited to, the following:

• Studies on descriptive epidemiology and trends (incidence, prevalence, morbidity, mortality) in diverse populations.
  Longitudinal cohort and other epidemiological studies that investigate risk and preventive factors associated with MCI/AD/ADRD and/or associated with neuropathological outcomes in diverse populations. Risk factors include genetic, environmental, modifiable, and co-morbidities.
  Studies of novel genetic variants that may have a strong genetic contribution to AD/ADRD biology.
  Studies that examine the association of highly prevalent co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease), cognitive impairment and AD/ADRD phenotypes.
  The role of early life co-morbidities such as childhood infections and diseases prevalent in LMICs.
  Impact of exposome (e.g., environmental exposures including environmental toxicants, air pollution, and diet) on brain health, AD/ADRD risk and Cognitive Reserve/Resilience.
  The role of infectious agents, including COVID-19 in cognitive impairment and AD/ADRD.
  Etiology of age-related AD/ADRD subtypes.
  Genetic and other -omics data: APOE status, genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics.
  Neurobiological and Neuropathological: Neuroimaging endpoints, including, but not limited to, the use of novel positron emission tomography (PET) ligands; cerebrospinal fluid, or blood-based biomarkers such as beta-amyloid, tau, and neurofilament; and autopsy tissue when possible.
  Physiology and other co-morbidities: Obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); brain stress measures (e.g., autonomic, cortisol, EEG, fNIRS); role of inflammation or immune systems; and mental health history.
  Identification of underlying mechanisms of cognitive reserve/resilience (e.g., protective genotypes of cognitive reserve).
  Development of accessible low-cost tools for diagnosis of AD/ADRD.
  Population-based research for the discovery or expansion of predictive pre-clinical biomarkers (e.g., blood, fluid, neuroimaging, language) associated with vascular or neurological changes in different populations.

Which applications are considered non-responsive to this NOFO?

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications that include non-human animals.
• Applications that include populations not from LMICs.
• Applications that do not propose research related to AD/ADRD neuroscience.
• Applications from high-income countries, as defined by the World Bank.
• Applications not from an established LMIC investigator.
• Applications which do not include a US collaborator.
• Applications that do not include US-LMIC collaborative MPI plan.

Please note that non-responsive applications will be withdrawn prior to review.

What are additional resources I can reference while developing my application?

Some relevant resources that you can reference are:

• Human, Health and Hereditary in Africa (H3Africa)
• Harnessing Data Science of Health Discovery and Innovation in Africa (DSI-Africa)
• Global Environmental and Occupational Health program (GEOHealth)
• Health and Retirement Study: International Family of Studies
• Harmonized Cognitive Assessment Protocol (HCAP) Network
• Gateway to Global Aging
• Alzheimer’s Disease Research Centers
• Alzheimer’s Disease Sequencing Project
• NIA’s Genetics of Alzheimer's Disease Data

Are Multiple PD/PIs required?

Yes. Multiple PD/PIs are required, and a Leadership Plan must be included in the application. Visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide .

Where can I find more information on how to apply to NIH?

Potential applicants can find instructions for how to apply in the SF424 Application Guide . Carefully follow the specific guidelines/requirements found in both the SF424 Application Guide and the instructions in the Notice of Funding Opportunity (NOFO). Be aware that the instructions in the NOFO supersede those found in the SF424 application guide.

Additionally, tips for NIH applicants are provided in a video Grant Writing for Success NIH [Video via CUGH TV/YouTube] in which reviewers and staff at the NIH offer their insights to scientists seeking to improve their chances of getting a grant from the National Institutes of Health.

See the Annotated Forms for tips on how to fill in the SF424 forms.

How do I find a US investigator to collaborate with?

You can find information about all funded NIH awards through the public database NIH RePORTER , which may be helpful in locating experts in specific scientific or geographic regions. Additionally, potential applicants may want to use World RePORT as a resource. This is an open-access, interactive mapping database project highlighting biomedical research investments and partnerships across many large funding organizations.

Is having and maintaining a System for Award Management (SAM) registration required for applications submitted to this NOFO?

Yes, the submitting institution and all PDs/PIs are required to register in order to submit an application using the online systems. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations:

• System for Award Management (SAM) – Applicants must complete and maintain an active entity registration (formerly CCR registration), which requires renewal at least annually. The renewal process may require as much time as the initial registration. Use the Sam.gov "Manage Entity" function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons - Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Find detailed instructions about this multiple step process .

Your organization must be registered in SAM and your SAM credentials must be active at time of grant submission and time of grant award. A yearly renewal process is required to keep your credentials active. SAM uses the term "entity" to refer to your organization.

Purpose of SAM

• SAM is a system required by the federal government to collect information on organizations applying for grants and contracts.
• SAM resources , see the Quick Start Guide for International Registrants

Note that NIH requires electronic applications, and it is critical that applicants complete all required registrations well in advance of the application deadline as the registration process can take several weeks or longer.

Do all PDs/PIs need to have an eRA Commons ID?

All PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. For additional information, see the eRA Commons Registration FAQs .

How do I find out more about NIH Cooperative Agreements?

The Cooperative Agreement (U Series) mechanism is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. The Cooperative Agreement Terms and Conditions of Award in the NOFOs describe the respective roles and responsibilities of PDs/PIs and U.S. Government staff, as well as areas of joint responsibility. U.S. Government Project Collaborators will be appointed at the time of award and will have substantial programmatic involvement by providing advisory input as described in the NOFOs. The role of the U.S. Government Project Collaborators will be to facilitate and not to direct activities.

Where can I find instructions for preparing my Biographical Sketch (Biosketch)?

Access Biosketch Format Pages, Instructions and Samples from the NIH Office of Extramural Research (OER).

Please also see the following NIH Guide notice for Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NOT-OD-21-073) .

Grants-Funding