Applicant Resources for RFA-AG-25-005: Open Measurement Coordinating Network for Non-Pharmacological Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Primary Prevention Trials (U24 Clinical Trial Not Allowed)

The frequently asked questions below are related to RFA-AG-25-005: Open Measurement Coordinating Network for Non-Pharmacological Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Primary Prevention Trials (U24 Clinical Trial Not Allowed) .

Frequently Asked Questions

Below are a list of frequently asked questions and answers.

Q: Is this RFA meant to support and extend the NIH Toolbox suite of measures?

A: NIA has listed several NIA-supported measurement projects that could be leveraged as resources for this Network, including NIH Toolbox , HRS-HCAP , Mobile Toolbox , NACC UDS , and the SOBC Measures Repository. The Network should leverage NIA-supported projects like these, but these are examples and not inclusive of all NIA-supported measurement projects and it is not a requirement to include any specific measurement project or group of projects.

Q: What is the overall goal of this Notice of Funding Opportunity (NOFO)?

A: The overall goal is to create infrastructure to support the coordination of measures and measurement methods development, validation, and standardization customized for individuals with different needs and linked to real-world function. This Notice of Funding Opportunity (NOFO) invites applications that propose to establish a national Open Measurement Coordinating Network for Non-Pharmacological AD/ADRD Primary Prevention Trials. The Network will serve as a centralized hub for developing, validating, standardizing, and disseminating measures and measurement methods for AD/ADRD primary prevention trials. It will incorporate measures and measurement methods across neuropsychological, biomarker, and functional domains to meet the goal of primary prevention of AD/ADRD centered around brain health equity.

Q: What is a main deliverable of this Network?

A: A main deliverable of this Network will be a core set of measures for AD/ADRD primary prevention trials that incorporates new targets for intervention.

Q: Is the focus of this NOFO on measurement development, AD/ADRD prevention, or both?

A: The overall goal is to create infrastructure to support the coordination of measures and measurement methods development, validation, and standardization customized for individuals with different needs and linked to real-world function. The Network will serve as a centralized hub for developing, validating, standardizing, and disseminating measures and measurement methods for AD/ADRD primary prevention trials. This NOFO is not intended to support the development of AD/ADRD primary prevention trials (Clinical Trials Not Allowed).

Q: What are open principles and practices?

A: Open principles and practices are central to this initiative. Network infrastructure will promote equity and innovation through an open-source model that emphasizes collaboration and transparency over traditional single-provider and proprietary models. Single-provider refers to a centralized system where all services and assessments are exclusively offered and controlled by one organization (e.g., academic institution, company). Open collaboration, including more inclusive and equitable research participation and practices, leads to more effective measurement development. When researchers from different fields, regions, and backgrounds collaborate, they can contribute unique insights and approaches to complex problems. Additionally, open collaboration facilitates transparency and improves the quality of research outcomes. Open software tools improve the quality and sustainability of research software in the face of ongoing technical enhancements and allow community development responsive to rapidly evolving needs. Open practices promote sharing of data, methods, and results, enabling other researchers to replicate and build upon existing work. It includes open measures and scoring algorithms, as well as open, but protected data.

Q: How do open principles and practices apply to the resources developed through this initiative?

A: The Network will enhance the sustainability and impact of research software tools by enabling the use of best practices and design principles in software development and leverage advances in computing in a modern data ecosystem. A successful Network will include collaborations between scientists and software engineers to optimize the design, implementation, and cloud-readiness of research software and to advance the principles and practices of open science. This initiative is aligned with the NIH Strategic Plan for Data Science , which describes actions aimed at building a better data infrastructure and a modernized data ecosystem as well as NIA Strategic Goal G: support the infrastructure and resources needed to promote high-quality research.

The NIH promotes sharing of research software and source code, developed under research grants or cooperative agreements in any stage of development, in a free and open format. Releasing the software source code in an “open” manner means that you permit users to use, modify, and/or redistribute the code. Data Management and Sharing Plans need to indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and the name of any required tool or software. Read about best practices for sharing research software , including NIA Research Software and Source Code Sharing Guidance .

Q: What is considered primary prevention of AD/ADRD?

A: Primary prevention refers to reducing the incidence of the disease by eliminating or treating specific risk factors, which may decrease or delay the development of AD/ADRD. Individuals currently without any signs or symptoms of AD/ADRD could remain without AD/ADRD through primary prevention. Secondary prevention aims to detect the disease at an early stage, before any symptom has emerged, when treatment could halt or limit its progression. This NOFO is focused on measures and measurement methods development and standardization for AD/ADRD primary prevention trials.

Q: Should the application focus only on Alzheimer’s disease?

A: Not necessarily. All measures and methods development and validation should establish the acceptability and feasibility of using the proposed instruments in both cognitively normal individuals and persons living with cognitive impairment (PLWCI), including subjective cognitive decline, MCI, and AD/ADRD across a variety of dementia subtypes including Alzheimer’s, vascular, Lewy body, and frontotemporal dementias. Special attention needs to be paid to measurement among high-risk individuals in midlife, including individuals with family history of AD/ADRD, those with predisposing risk factors, and those in health disparities populations known to be at greater risk for AD/ADRD, but it is not a requirement to study individuals with preclinical AD/ADRD (i.e., presence of AD/ADRD brain pathology without evidence of cognitive impairment), subjective cognitive decline, or diagnosed MCI or AD/ADRD. Enrollment of individuals with early stages of disease, including MCI, in measurement development and validation studies could be justified to establish predictive validity for detection of disease-related changes tracked longitudinally that may be decreased or delayed as a result of primary prevention.

Q: Am I required to include a health disparities focus in my application?

A: NIA encourages applications that focus on individuals in midlife who are at greater risk for AD/ADRD, including health disparities populations, but this is not a requirement. NIA is particularly interested in proposals that advance equity for populations disproportionately impacted by AD/ADRD.

Q: What are “traditional single-provider and proprietary models”? Multiple universities with control? Open-source availability of technology and measures?

A: Network infrastructure will promote equity and innovation through an open-source model that emphasizes collaboration and transparency over traditional single-provider and proprietary models. Single-provider refers to a centralized system where all services and assessments are exclusively offered and controlled by one organization (e.g., academic institution, company). The NIH promotes sharing of research software and source code, developed under research grants or cooperative agreements in any stage of development, in a free and open format. Releasing the software source code in an “open” manner means that you permit users to use, modify, and/or redistribute the code.

Q: Should preliminary data be included?

A: Preliminary data and evidence that the proposed team has successfully worked together to execute the infrastructure plan would be appropriate.

Q: How much funding will NIA allocate to the NOFO and what is the project period? Does the budget plan need pre-approval?

A: NIA intends to commit $8,000,000 in total costs in FY 2025 to fund one award. The scope of the proposed project should determine the project period. The maximum project period is 5 years. Application budgets do not need pre-approval. The budgets are not limited but need to reflect the actual needs of the proposed project.

Q: When is the application due?

A: New applications are due by June 15, 2024. Earliest submission date is May 15, 2024.

Q: Are there any required activities?

A: Yes. See Section IV of the NOFO under the Research Plan.

Q: Is a letter of intent required?

A: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be addressed to:

Luke Stoeckel, PhD and Kristina McLinden, PhD
National Institute on Aging (NIA)
Email: NIAOpenMeasure@nih.gov

Q: Are foreign institutes eligible?

A: Yes.

Q: Where will this be reviewed?

A: This is expected to be reviewed by the NIA Scientific Review Branch.

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Q: Are there special review criteria?

A: Yes. Please review Section V: Application Review Information of the NOFO carefully.

Q: Is my application responsive?

A: This NOFO is NOT intended to fund the following:

  • Applications that do not describe how the proposed Network will be able to achieve each of the three objectives and five required activities described in Section IV - Research Plan.
  • Applications that do not propose to assess reliability and validity of proposed measures in cognitively normal as well as cognitively impaired individuals.
  • Applications that do not propose a well-defined set of milestones and a timeline for accomplishing the network activities.
  • Applications that do not propose a plan that aligns with open science practices and principles as described above.
  • Applications that do not include a detailed data management and sharing plan for rapid and broad sharing of all guidance, practices, measures, and data developed by the Network.
  • Applications that do not include a sustainability plan to support Network activities and resources.

For more information, visit NIH's webpage and NIA's webpage on these topics.

See Section VIII. Other Information for award authorities and regulations.

Q: What are the requirements for senior/key person profile?

A: The applicant must propose PD(s)/PI(s) and other personnel well suited to implement the activities of the Network. Specifically, the PD(s)/PI(s) must have the following experience:

  • Demonstrated experience, and an ongoing record of accomplishments, in managing measurement research projects including multi-level data (e.g., cognitive, behavioral, social/structural, computational, biological) and research resources.
  • Experience coordinating collaborative research.
  • Experience with open science practices and principles.
  • Experience appropriate to support the development and implementation of relevant measurement resources.

Key personnel must include individuals with the following experience:

  • Demonstrated experience in the fields of cognitive, behavioral, social/structural, computational, biological research relevant to AD/ADRD.
  • Demonstrated experience in resource sharing through web-based platforms or other means.
  • Demonstrated experience overseeing the selection and management of sub awards.

If the application is multi-PD/PI, the investigators must have complementary and integrated experience, as well as clear governance plans, for the administration of the proposed Network.

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the Network to avoid establishing conflicts of interest throughout the field. Participation in Network activities, including attending meetings to offer scientific consultation, receiving pilot funding, or collaborating on measure or data development activities will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application.

Applicants should NOT name proposed members of the Network Advisory Committee referenced below in the Research Strategy instructions. The panel will be established post award in collaboration with NIA staff.

Q: What is a cooperative agreement and how does it differ from a grant?

A: The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH. The Network team will include an NIA Program Officer, NIA Project Scientists, Network Steering Committee, Network Advisory Panel, and Community Advisory Panel.

Q: What NIA resources are available to applicants?

General:

Meetings:

AD/ADRD infrastructure projects for dissemination purposes:

NIA-supported measurement projects most relevant to this NOFO: NIH Toolbox , HRS-HCAP , Mobile Toolbox , NACC UDS , SOBC Measures Repository

NIA Research Software and Source Code Sharing Guidance , including best practices for sharing research software

Q: Who do I contact if I have further questions?

Application Submission Contacts

  • eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

  • Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

    • Telephone: 301-402-7469 or 866-504-9552
  • General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
  • Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)

Scientific/Research Contacts

Luke Stoeckel, PhD and Kristina McLinden, PhD
National Institute on Aging (NIA)
Email: NIAOpenMeasure@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov

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