This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Alzheimer’s Research Program

Transforming Diagnosis Award

Funding Opportunity Number: HT942526AZRPTrDA

Pre-Application Due: June 22, 2026

Application Due: September 24, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Alzheimer’s Transforming Diagnosis Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Transforming Diagnosis Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Alzheimer’s Transforming Diagnosis Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Alzheimer’s Transforming Diagnosis Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Alzheimer’s Research Program (AZRP) Transforming Diagnosis Award (TrDA) supports non-incremental, solutions-oriented research that reduces or overcomes important barriers to obtaining a diagnosis, meaningful disease monitoring and accurate prognosis.

Distinctive Features:

• Clinical research is allowed, however clinical trials and animal research are prohibited.

• Preliminary data are required.

• Community collaboration is required for studies prospectively enrolling human subjects.

• Study Population: The AZRP encourages studies to leverage existing cohorts/datasets.

Cohorts consisting of individuals 65 years or younger are also encouraged.

• Career Initiation or Transition (CIT) Partnership Option: The TrDA includes an option for more than one PI and supports both new and existing collaborative partnerships. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). If utilizing this option, at least one independent investigator must meet the CIT Partnership Option eligibility requirements at the time of application submission.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $3.2M to fund approximately two TrDA applications with total cost caps of $1.5M per award for the single PI option and $1.7M combined for the CIT Partnership Option. The maximum period of performance is 4 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 22, 2026

• Invitation to Submit an Application: August 10, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 24, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 29, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526AZRPTrDA

Assistance Listing Number: 12.420 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named as Principal Investigator (PI), Initiating PI, or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status. Individuals in mentored positions (e.g., postdoctoral fellows, clinical fellows) are not considered independent investigators.

CIT Partnership Option:

At least one independent investigator must meet the CIT Partnership Option eligibility requirements.

• Career Initiation investigators must have at least three years of research experience beyond a terminal degree but no more than seven years within their first independent research position with only nominal, if any, research support or publications in the field. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application.

• Career Transition investigators may be any level, but new to military health, traumatic brain injury, and/or AD/ADRD fields, with nominal, if any, publications and/or research support for their intended field.

Application Limit: The same independent investigator may not be named as a PI, Initiating PI, or Partnering PI on more than four (4) TrDA applications.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Alzheimer’s Research Program (AZRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the AZRP in 2011 to provide support for Alzheimer’s disease research of high potential impact and exceptional scientific merit. Appropriations for the AZRP from FY11 through FY25 totaled $213 million (M). The FY26 appropriation is $15M.

AZRP Vision Statement: Mitigate the impact of Alzheimer’s and related dementias associated with traumatic brain injury (TBI), military and diverse risks.

AZRP Mission Statement: Fund impactful, solution-oriented research to address critical needs and improve quality of life for Service Members, Veterans, their Families, and the public who are living with Alzheimer’s disease and related dementias.

3.1. Award History

The AZRP Transforming Diagnosis Award (TrDA) mechanism was first offered in FY23. Since then, 93 TrDA applications were received, and eight were recommended for funding.

3.2. Intent of the Transforming Diagnosis Award

The FY26 AZRP TrDA intends to support non-incremental, solutions-oriented research that reduces or overcomes important barriers to obtaining a diagnosis, meaningful disease monitoring and accurate prognosis. Barriers could include, but are not limited to, technologies, cost, patient access to diagnosis/prognosis technology, diagnosis management, applicability, clinical implementation, relationship to clinical outcome measures, biomarker validation, and lack of longitudinal data to inform prediction/prognosis. In addition, the FY26 AZRP TrDA encourages applications that address health disparities in Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Dementias (ADRD) research.

Applications that do not clearly delineate how the proposed research addresses and/or overcomes current challenges for diagnosis and/or prognosis do not meet the intent of this mechanism.

Funded research should provide significant impact on the AD/ADRD field, Community, and military health. For the purposes of this funding opportunity, the following terms are defined as:

• Military or military health refers to not only members of all components of the Armed Forces, but Veterans, their Families and other DOW beneficiaries.

• Community encompasses the network of individuals living with an AD/ADRD diagnosis, their care partner(s), families, advocates, and/or other close connections. The CDMRP refers to these individuals as consumers.

3.2.1. Key Elements for the TrDA

• Preliminary data are required. Applicants must provide sufficient preliminary data to support the rationale for the proposed research and associated endpoints.

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• Clinical trials are not allowed within this funding opportunity. However, projects may include clinical research. Animal research is prohibited.

• Biomarker Studies: Projects may include elements of biomarker validation, including increasing inclusivity and applicability of biomarkers, but projects where the primary goal is basic biomarker discovery are not supported.

• Identified Pathway to Applicability: Applications should be focused on a clear pathway to clinical applicability. Proposed projects should identify and clearly articulate how the projects address gaps limiting advances in early, available, and rapid diagnosis and/or prognosis.

• Study Population: The proposed research should be representative of the characteristics and priorities of the population(s) intended to benefit from the research. This is a high priority for the program as it provides critical context to enhance the quality and impact of research. The AZRP encourages studies to leverage existing cohorts or datasets. Cohorts consisting of individuals 65 years or younger are encouraged. There is no requirement for any specific research population, such as Service Members or Veterans. Instead, the AZRP encourages investigators to consider how their research from a civilian cohort might apply to such populations, and vice versa.

• Pathway to Clinical Application: Applicants must provide a plan to transition research outcomes to clinical application through engagement of both the scientific and the lived experience community(ies). This information will be captured in Attachment 7, Post-Award Progression Plan.

• Community-Informed Research: Research funded by the FY26 AZRP should be responsive to and informed by the needs of people living with AD/ADRD and their Communities. Applicants should leverage patient and/or caregiver perspectives to inform the proposed research question, study design, and actions to lower the burden of participating in research.

For the FY26 AZRP TrDA, Community collaboration is required for studies prospectively enrolling human subjects. To maximize the impact and implementation of the proposed research, teams are expected to form effective and equitable partnerships with members of the AD/ADRD lived experience Community.

• CIT Partnership Option: The TrDA includes an option for more than one PI. The TrDA supports both new and existing collaborative partnerships. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.2.2. Other Important Considerations for the TrDA

Community collaboration in research is defined by the AZRP as research that incorporates shared responsibility and ownership of a research project between the scientific investigators and Community members.

Community collaboration supports strengths-based approaches where scientific researchers and Community members work in partnership on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation and https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes

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FY26 Alzheimer’s Transforming Diagnosis Award 8 dissemination. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for Community-level interventions and can also augment the potential impact of a research program on people living with dementia, their families and/or their care partners.

These collaborative relationships are often established through integrating Community members and/or organizations into research teams as co-researchers, advisory board members and consultants. It is up to each applicant to choose the appropriate approach that is best suited for the unique needs of the research project.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is 4 years.

3.4.1. Application Submission With a Single PI

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.5M.

3.4.2. Application Submission With the CIT Partnership Option

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $1.7M.

A separate award will be made to each PI’s organization.

The PIs are expected to be partners in the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:~:text=APPENDIX%2010.%0ADOW%20AND%20VA%20WEBSITES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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3.4.3. For Both Options Within This Award Mechanism

If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the AZRP TrDA.

• Costs associated with data and research resource sharing.

• Costs associated with the Community collaborative research approach (e.g., consultant costs, capacity-building exercises).

• Research subject compensation and reimbursement for study-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, resources/equipment to enable participation).

Must not be requested for:

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

• Animal costs.

• Clinical trial costs.

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

The PI or Initiating PI must submit the following pre-application components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (two-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Background and Rationale: Briefly describe the important barrier to obtaining a diagnosis, meaningful disease monitoring, and accurate prognosis to be addressed by the research. Describe the scientific rationale on which the proposed work is based;

include relevant preliminary data and literature citations.

○ Specific Aims and Study Design: Concisely state the hypothesis and specific aims and provide a brief overview of the study design. If prospective human subjects research is proposed, indicate how the research or study design is informed by the lived experience Community and/or patient perspectives research.

○ Adherence to the Intent of the Funding Opportunity: Describe how the proposed research is responsive to the intent of the FY26 TrDA.

○ Impact: Describe the potential impact to people living with AD/ADRD, their families, or care partners using lay language. Guidelines for writing in lay language, also known as plain language, can be found online.

○ Partnership: For preapplications submitted under the CIT Partnership Option, briefly describe the qualifications of the two PIs and how their collaborative efforts will better address the research question.

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• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ Other Pre-Applications (two-page limit): If applicable, provide a list of all FY26 TrDA pre-applications where the PI is also named as a PI, Initiating PI, Partnering PI, or collaborator. Each entry must include the CDMRP log number, the PI's role, the project title, the specific aims, and a brief explanation of how each pre-application's research questions are distinct.

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

CIT Partnership Option: The CDMRP requires separate full application package submissions for the Initiating PI and Partnering PI, even if the PIs are located within the same organization.

The application submission process for the Partnering PI uses an abbreviated full application package.

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

4.3.1. Full Application Components for the PI or Initiating PI

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (15-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

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– Background/Rationale: Present the ideas and scientific rationale behind the proposed research project. Provide a review and analysis of relevant literature and completed/ongoing studies, including preliminary studies and preclinical data. If prospective human subjects research is proposed, describe how lived experience Community and/or patient perspectives informed the research. Describe how this proposed research represents a non-incremental, solutions-oriented advance upon the existing knowledge.

– Specific Aims/Objectives: Clearly and concisely explain the project’s specific aims, objectives and hypotheses. If the proposed research project is part of a larger study, present only tasks that this AZRP award would fund.

– Preliminary Data: Clearly demonstrate that there is sufficient evidence to support the proposed stage of research. Provide preliminary data to support the proposed research and endpoints to be measured.

– Research Strategy: Outline the approach for executing non-incremental/iterative research and provide sufficient detail for evaluation of its appropriateness and feasibility. Consult the appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Identify and describe how the study design, methods, models, and analysis of research outcomes will address the project’s specific aims and hypotheses.

❖ For studies performing deidentified or prospective human subject recruitment or observation, briefly describe the population(s) of interest and how access to the population(s) or dataset(s) will be achieved. Full details on prospective human subject recruitment will be required in the Study Population Recruitment and Safety Plan (Attachment 10).

❖ If prospective human subjects research is proposed, describe how community/patient perspectives informed the study design.

❖ If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Note that CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOW or VA patient populations, resources, or databases. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the General Application Instructions, Appendix 4, for additional considerations.

▪ Describe how the proposed project is feasible and will be completed within the proposed performance period.

❖ Describe potential problem areas and provide alternative methods and approaches.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application.

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▪ Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

▪ Describe the strategy for how sex will be considered as a biological variable will be requested in Attachment 2.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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Questionnaires and Other Research Data Collection Instruments: Include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides or other instruments. This should include any drafts that are currently in use or underdevelopment.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies)1 where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan, which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

Quad Chart: Provide a Quad Chart for the proposed project. The format for the Quad Chart is available on the eBRAP “Funding Opportunities & Forms” web page at (https://ebrap.org/eBRAP/public/Program.htm).

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project and explain how it is Community-informed.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached.

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls and, if applicable, Community collaboration integration.

1 NIH-supported Data Repositories can be found at https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/Program.htm https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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Impact: Briefly describe how the proposed research project, if successful, will transform and make important contribution(s) to the AD/ADRD research, patient care, and/or quality of life.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research.

– What population will the research help, and how will it help them?

– What are the potential applications, benefits, and risks of the anticipated outcomes?

– What are the likely contributions of the proposed research project to advancing research, patient care and/or quality of life?

– What is the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families?

– How soon would the proposed research result in a solution that helps people living with or at risk of AD/ADRD, their care partners and/or families? Describe the potential applications, benefits, and risks of the anticipated outcomes with a realistic timeline.

– Overall, how will the contributions of the proposed research project advance dementia care and quality of life?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work.

The SOW should state the specific aims described in the Project Narrative and include a list of major tasks and subtasks that support the completion of the stated aims, including milestones for completing the aims during the period of performance. The SOW should describe only the work for which funding is being requested by this application and, as applicable, should also include the following tasks/subtasks:

– Include milestones associated with data or research resource(s) sharing and, if applicable, executing the community collaboration plan.

– CIT Partnership Option: Each PI must submit an identical copy of a jointly created SOW. The specific contributions of the Initiating PI and the Partnering PI should be clearly noted for each task.

○ Attachment 6: Impact Statement (two-page limit): Upload as “Impact.pdf”. The Impact Statement is considered by reviewers on the peer review and programmatic review panels and therefore should be written in a manner that will be readily understood by the general public, especially those without a background in science or medicine. Avoid scientific jargon, acronyms and abbreviations.

Clearly detail the impact of the proposed research outcomes as if the proposed project is successful in all its aims.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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– How will the research outcomes reduce or overcome important barriers to obtaining a diagnosis, meaningful disease monitoring, and accurate prognosis?

– If the aims of the project are successful, how and when will the research outcomes improve care?

▪ What immediate and potential long-term benefit(s) does successful completion of this project yield for people living with TBI and/or AD/ADRD, their families and care partners/caregivers?

▪ How would the results from this project transfer from a civilian to military population, or vice versa?

▪ If applicable, how can the anticipated research outcomes improve the understanding of health differences between the sexes?

– What potential issues might limit or lessen the impact of the proposed research, and what strategies could overcome those issues?

○ Attachment 7: Post-Award Progression Plan (three-page limit): Upload as “Progression.pdf”. The AZRP requires all applicants to provide a feasible implementation plan for the research proposed and how the research will ultimately lead to clinical application for intended populations. Applicants should identify the next logical and feasible steps following the period of performance. Assuming the project is successful in all its aims:

– Outline the next immediate and subsequent logical steps to be taken following the period of performance to progress the research to clinical applicability. Describe the timeline needed with defined milestones. If further research is required, describe why this additional study is needed and how those outcomes would contribute to progressing the research toward clinical utility. Include steps necessary for regulatory interactions, if applicable.

– Describe how the bidirectional feedback and dissemination from the AD/ADRD/TBI Community will be integrated into the progression of this research.

– Describe collaborations and other resources (e.g., clinical partners, commercial partners, manufacturing partners, clinical practice guideline development/execution committees, training providers/resources) that are in place or will be established to reach the milestones described above.

– As appropriate, discuss ownership rights/access to the intellectual property necessary for the development and/or commercialization of products or technologies supported with this award. Include a plan for resolving intellectual and material property issues among participating organizations. If the intellectual property rights are not owned by the applicant, PI, or a member of the study team, describe the planned next steps necessary to make the product(s) available to the AD/ADRD/TBI Community.

○ Attachment 8: Community Collaboration Plan (required for research prospectively enrolling human subjects): Combine and upload as a single file named “Collaboration.pdf”. Refer to Section 3.2.2, Other Important Considerations for the TrDA, for more details regarding the Community collaboration requirement. This attachment must be written in a manner that is readily understood by the general public, especially those without a background in science or medicine. Avoid scientific jargon, acronyms and abbreviations.

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– Collaborative Research Statement (three-page limit is recommended): Describe the collaborative research approach that will be used (e.g., lived experience consultants, partnership with Community-based organization, community advisory board, co-researcher model). Detail when and how the approach will be used within the research project; how input will be meaningfully incorporated into the research design, execution, and dissemination; and explain how this best serves the Community/intended user base.

▪ Name the individuals(s) participating, and describe how the Community collaborator(s) are connected to your study population(s).

▪ Describe any training, co-learning, or capacity-building activities that will be provided to both scientific researchers and Community members on collaborative research approaches, decision-making and equitable participation.

– Letters of Community Collaboration (two-page limit per letter is recommended): Provide a letter signed by each Community partner confirming their role and commitment to participate on the research team. If a Community-based organization will be engaged, the letter of commitment should be signed by both the organization point of contact leading the engagement and the organization’s leadership endorsing the collaboration. The letter should explain how the individual’s qualifications and background will benefit the proposed research project.

○ Attachment 9:…