Opportunity Information: Apply for PAR 23 154
The National Institutes of Health (NIH) funding opportunity PAR-23-154, titled "Development and Validation of Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 - Clinical Trial Not Allowed)," is a discretionary grant program designed to push the field toward more clinically relevant experimental models of Alzheimers disease and related dementias, including dementias that develop after traumatic brain injury (post-TBI dementias). The central aim is to support both the creation of new models and the rigorous validation of those models so they better mirror what actually happens in people, rather than producing findings that only apply in narrow laboratory settings.
This opportunity focuses on model systems that can be used to study disease mechanisms and, importantly, to support therapy development by improving confidence that preclinical results will translate into humans. NIH is open to a wide range of model types, including small animal models (such as rodents), larger animal models, ex vivo models (for example, organotypic slice cultures or explanted tissues), human induced pluripotent stem cell (iPSC)-based systems, and other in vitro approaches. The emphasis is not on using a single preferred platform, but on whether the model can credibly represent human AD/ADRD biology, progression, and clinical features. Because the announcement explicitly states "Clinical Trial Not Allowed," the work should be preclinical or mechanistic rather than interventional studies in human participants that meet the NIH definition of a clinical trial.
A major feature of this FOA is the expectation of thorough validation. Applicants are encouraged to build a convincing case that a proposed model is not just novel, but meaningfully aligned with human disease. Validation may include internal validation (showing the model is stable, reproducible, and behaves consistently), face validation (the model resembles human disease features such as pathology, cognitive impairment, or biomarker patterns), construct validation (the biology and causal mechanisms match what is believed to drive disease in humans), and predictive validation to the extent possible (the model responds to interventions in ways that are consistent with human outcomes, or at least aligns with known therapeutic successes and failures where relevant). The FOA highlights multiple ways to do this, including interrogating underlying mechanisms and pathways, using functional imaging, assessing behavior, and collecting cognitive or other functional readouts that connect more directly to clinical symptoms. Independent replication is also encouraged, reflecting NIHs interest in models that stand up across labs and are not overly dependent on a single set of hands or a single experimental environment.
NIH also signals strong interest in models that reflect the complexity of real-world disease, not just isolated pieces of pathology. Novel models of complex pathology, mixed etiologies, or comorbid conditions are encouraged. In practical terms, this could mean models that incorporate multiple risk factors and interacting variables such as genetics, age, environment, lifestyle exposures, vascular contributions, metabolic factors, inflammation, or prior brain injury. The goal is to better capture the kinds of multifactor interactions seen in patients, where AD/ADRD often develops over time and alongside other health conditions. New models are expected to be innovative and to fill a clear gap in the current landscape of AD/ADRD models, rather than being minor variations of existing approaches.
The activity uses an R61/R33 phased innovation mechanism. In general, this type of structure is intended to support an initial, milestone-driven development stage (R61) followed by a second stage focused on expanded validation and/or further development (R33), with progression tied to successful completion of predefined objectives. The funding instrument is a grant under NIH, and the activity category is health-related research. The opportunity lists CFDA numbers 93.853 and 93.866, reflecting the NIH programs under which the funding is administered. The posted award ceiling is $360,000, and the original closing date shown in the source information is 2023-10-20.
Eligibility is broad and includes many domestic U.S. organization types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are stated as not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant can include certain project elements performed abroad when justified and compliant with NIH policy.
Overall, the grant is aimed at strengthening the foundation of AD/ADRD research by producing models that are both more human-relevant and more rigorously tested. NIH is clearly trying to address a persistent bottleneck in dementia research: having experimental systems that can reliably predict human biology and therapeutic response. Applicants that can show a genuine unmet need in current models, propose a thoughtful plan to demonstrate internal consistency and clinical relevance, and incorporate the complexity of patient risk profiles and comorbidities are aligned with the core intent of this opportunity.Apply for PAR 23 154
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and Validation of Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
- This funding opportunity was created on 2023-04-11.
- Applicants must submit their applications by 2023-10-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $360,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity PAR-23-154?
PAR-23-154 is an NIH discretionary grant funding opportunity titled "Development and Validation of Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 - Clinical Trial Not Allowed)." It supports the development of new experimental models and the rigorous validation of those models so they better reflect what happens in people with Alzheimers disease and related dementias.
What is the main goal of this grant program?
The central goal is to move the field toward more clinically relevant AD/ADRD model systems that are reliable, reproducible, and meaningfully aligned with human disease biology, progression, and clinical features. A key motivation is improving confidence that preclinical findings will translate into humans, especially for therapy development.
What diseases or conditions are included under AD/ADRD in this opportunity?
The opportunity targets Alzheimers disease and related dementias (AD/ADRD). It also explicitly includes dementias that develop after traumatic brain injury (post-TBI dementias).
Is this opportunity meant for therapy development, basic research, or both?
Both are supported in the sense that the models may be used to study disease mechanisms and to support therapy development. The emphasis is on building and validating model systems that can underpin mechanistic work and improve the translational value of preclinical therapeutic testing.
Are clinical trials allowed under this FOA?
No. The title specifies "Clinical Trial Not Allowed," so the work is expected to be preclinical or mechanistic rather than interventional studies in human participants that meet the NIH definition of a clinical trial.
What kinds of models are responsive to this funding opportunity?
NIH is open to a wide range of model systems, including small animal models (such as rodents), larger animal models, ex vivo models (such as organotypic slice cultures or explanted tissues), human induced pluripotent stem cell (iPSC)-based systems, and other in vitro approaches. The key consideration is whether the model can credibly represent human AD/ADRD biology, progression, and clinical features.
Does NIH prefer a specific model platform (e.g., rodents or iPSC systems)?
No single platform is presented as preferred. The emphasis is on the model's ability to reflect human-relevant disease biology and on the strength and rigor of the validation plan.
What does "development and validation" mean in the context of this FOA?
It means the opportunity is not only about creating new models; it also expects applicants to test and document how well a model maps to human disease and how reliably it performs. Validation is treated as a major feature of the program rather than a secondary or optional activity.
What types of validation are applicants encouraged to include?
The FOA highlights several validation dimensions: internal validation (stability and reproducibility), face validation (similarity to human disease features such as pathology, cognitive impairment, or biomarker patterns), construct validation (alignment of biology and causal mechanisms with what is believed to drive disease in humans), and predictive validation where possible (model responses that align with known therapeutic successes and failures or human outcomes).
What is internal validation for an AD/ADRD model?
Internal validation refers to demonstrating the model is stable and reproducible, behaves consistently, and yields reliable results rather than outcomes that depend heavily on a specific lab environment or unique handling.
What is face validation in this opportunity?
Face validation refers to showing the model resembles human disease features, which may include pathology, cognitive impairment, and/or biomarker patterns that are relevant to AD/ADRD.
What is construct validation in this opportunity?
Construct validation means demonstrating that the underlying biology and causal mechanisms in the model match what is believed to drive AD/ADRD in humans.
What is predictive validation and is it required?
Predictive validation is the extent to which a model responds to interventions in ways consistent with human outcomes, or at least aligns with known therapeutic successes and failures where relevant. The FOA encourages predictive validation "to the extent possible," recognizing it may not always be feasible in every model, but it is clearly valued when it can be done.
What kinds of assessments does NIH suggest for validating models?
The FOA highlights approaches such as interrogating underlying mechanisms and pathways, using functional imaging, assessing behavior, and collecting cognitive or other functional readouts that connect more directly to clinical symptoms.
Is independent replication encouraged?
Yes. Independent replication is encouraged, reflecting NIH's interest in models that hold up across laboratories and are not overly dependent on a single experimental environment or workflow.
What does NIH mean by models that reflect "real-world" disease complexity?
NIH is signaling interest in models that capture multifactor interactions seen in patients rather than isolated pathology. This includes models with complex pathology, mixed etiologies, and/or comorbid conditions.
What kinds of risk factors or comorbidities does the FOA mention as relevant?
The FOA provides examples such as genetics, age, environment, lifestyle exposures, vascular contributions, metabolic factors, inflammation, and prior brain injury. The intent is to incorporate interacting variables that better reflect patient risk profiles and how AD/ADRD develops over time alongside other health conditions.
Are minor variations of existing AD/ADRD models considered responsive?
The FOA emphasizes that new models are expected to be innovative and fill a clear gap in the current landscape, rather than being minor variations of existing approaches.
What funding mechanism is used in PAR-23-154?
This opportunity uses the NIH R61/R33 phased innovation mechanism.
How does the R61/R33 phased approach work at a high level?
It generally supports an initial, milestone-driven development stage (R61) followed by a second stage (R33) focused on expanded validation and/or further development. Progression to the R33 phase is tied to successful completion of predefined objectives.
What is the activity category for this funding opportunity?
The activity category is health-related research.
What are the CFDA numbers associated with this opportunity?
The opportunity lists CFDA numbers 93.853 and 93.866.
What is the posted award ceiling?
The posted award ceiling shown in the provided information is $360,000.
What is the closing date shown for this opportunity?
The original closing date shown in the provided information is 2023-10-20.
Who is eligible to apply?
Eligibility is broad and includes many domestic U.S. organization types, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), and faith-based or community-based organizations, among others.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Can foreign (non-U.S.) institutions apply as the applicant organization?
No. Foreign institutions (non-U.S. entities) are stated as not eligible to apply as applicant organizations.
Can a U.S. applicant include foreign components or work performed abroad?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. This means a U.S. applicant can include certain project elements performed abroad when justified and compliant with NIH policy.
What kinds of projects are a strong fit for this FOA based on the description?
Projects that address an unmet need in existing AD/ADRD models, propose an innovative model or substantial improvement that fills a clear gap, and include a rigorous validation strategy (including reproducibility and alignment with human disease) are aligned with the core intent. Models that incorporate patient-like complexity, such as mixed etiologies and comorbidities, also fit the priorities described.
What problem in dementia research is NIH trying to address with this opportunity?
The opportunity is aimed at reducing a major bottleneck: the lack of experimental systems that reliably predict human biology and therapeutic response. By funding model development plus thorough validation, NIH is trying to strengthen the foundation for translational AD/ADRD research.
Browse more opportunities from the same category: Health
Next opportunity: BJA FY 23 Virtual Reality De-escalation Site-Based Initiative
Previous opportunity: Cooperative Agreement for CESU-affiliated Partner with Chesapeake Watershed Cooperative Ecosystem Studies Unit
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 23 154
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 23 154) also looked into and applied for these:
| Funding Opportunity |
|---|
| Institutional Training Programs to Advance Translational Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (T32 Clinical Trial Not Allowed) Apply for PAR 23 163 Funding Number: PAR 23 163 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Centers of Excellence in Genomic Science (RM1 Clinical Trial Optional) Apply for PAR 23 098 Funding Number: PAR 23 098 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH): Data Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA MH 23 106 Funding Number: RFA MH 23 106 Agency: National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH) (U01 Clinical Trial Optional) Apply for RFA MH 23 105 Funding Number: RFA MH 23 105 Agency: National Institutes of Health Category: Health Funding Amount: $2,500,000 |
| International Research in Infectious Diseases (R01 Clinical Trial Not Allowed) Apply for RFA AI 23 023 Funding Number: RFA AI 23 023 Agency: National Institutes of Health Category: Health Funding Amount: $125,000 |
| Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed Apply for PAR 23 268 Funding Number: PAR 23 268 Agency: National Institutes of Health Category: Health Funding Amount: $295,924 |
| Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed) Apply for PAR 23 267 Funding Number: PAR 23 267 Agency: National Institutes of Health Category: Health Funding Amount: $295,924 |
| Assay Development and Screening for Discovery of Validated Chemical Hits for Brain Disorders (R01 Clinical Trial Not Allowed) Apply for PAR 23 168 Funding Number: PAR 23 168 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Draft Notice of Funding Opportunity - Children, Adolescents, and Families in the HIV Epidemic in Free State Province Apply for 72067423RFI00003 Funding Number: 72067423RFI00003 Agency: South Africa USAID-Pretoria Category: Health Funding Amount: Case Dependent |
| Mentored Career Transition Award for Intramural Fellows (K22 Clinical Trials Not Allowed) Apply for PAR 23 149 Funding Number: PAR 23 149 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Mentored Career Transition Award for Intramural Fellows (K22 Clinical Trials Required) Apply for PAR 23 150 Funding Number: PAR 23 150 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed) Apply for PAR 23 169 Funding Number: PAR 23 169 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
| Synthetic Nucleic Acid Platforms for HIV-1 (SNAPH): (R61/R33 Clinical Trial Not Allowed) Apply for RFA AI 23 026 Funding Number: RFA AI 23 026 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Small Research Grant Program for the Next Generation of Researchers in AD/ADRD Research (R03 Clinical Trial Optional) Apply for PAR 23 179 Funding Number: PAR 23 179 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Maximizing Investigators Research Award (MIRA) for Early Stage Investigators (ESI) (R35 - Clinical Trial Optional) Apply for PAR 23 145 Funding Number: PAR 23 145 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Nursing Home EXplanatory Clinical Trials Network (NEXT) (U24 Clinical Trial Required) Apply for RFA AG 24 016 Funding Number: RFA AG 24 016 Agency: National Institutes of Health Category: Health Funding Amount: $2,300,000 |
| Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional) Apply for RFA EB 23 005 Funding Number: RFA EB 23 005 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NEI Center Core Grant for Vision Research (P30 Clinical Trial Not Allowed) Apply for PAR 23 175 Funding Number: PAR 23 175 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| APS - Strengthening Health Services, Demand, and Systems in Benin Apply for 72068023APS00001 Funding Number: 72068023APS00001 Agency: Benin USAID-Cotonou Category: Health Funding Amount: $65,000,000 |
| NINDS Sustainable Transformation of Institutional Research Rigor (STIRR) Program (RC2 - Clinical Trial Not Allowed) Apply for RFA NS 24 020 Funding Number: RFA NS 24 020 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 23 154", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.