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Grant Analysis

Purpose & Target

This grant aims to support research that enhances the understanding of mechanisms underlying neuropsychiatric symptoms (NPS) in individuals with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The goal is to advance mechanistic understanding of biobehavioral and neurobiological pathways to identify novel therapeutic targets for treating and preventing NPS. - Target recipients: Research institutions including universities, non-profits, for-profit organizations (including small businesses), and government entities. - SECTOR-SPECIFIC: Focuses on biomedical, behavioral, and social sciences research related to Alzheimer's and dementias. - Geographic scope: Open to domestic (U.S.) and non-domestic (non-U.S.) entities (foreign organizations). - Key filtering criteria: Focus on mechanistic research for NPS in AD/ADRD, clinical trial optional (R21 mechanism for high-risk/high-reward projects lacking extensive preliminary data). - Grant frequency: Recurring (reissue of previous PARs), with multiple submission dates through September 2026.

Financial Structure

Award budget for direct costs: Combined budget for the two-year project period may not exceed $275,000.
Annual direct cost limitation: No more than $200,000 may be requested in any single year.
Project period: Maximum of 2 years.
Currency: USD.
Cost sharing: Not required.
Eligible costs: Not explicitly detailed but implies standard research costs, including budget for data submission to NIMH Data Archive (NDA).
Ineligible costs: Studies whose purpose is to evaluate safety, clinical efficacy, effectiveness, and management, and/or implementation of new interventions are not supported.
Payment schedule: Not specified, but standard NIH grant mechanisms typically involve reimbursements or advances based on expenditures.
Financial reporting: Annual Research Performance Progress Reports (RPPR) and final financial statements are required.

Eligibility Requirements

Organizational Eligibility

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With 501(c)(3) IRS Status (other than Higher Education), Without 501(c)(3) IRS Status (other than Higher Education).
For-Profit Organizations: Small Businesses, For-Profit Organizations (other than Small Businesses).
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized or Other).
Federal Governments: Eligible Agencies of the Federal Government, U.S. Territory or Possession.
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations.
Non-domestic (non-U.S.) Entities (Foreign Organizations): Eligible to apply, including non-U.S. components of U.S. organizations.

Required Registrations

System for Award Management (SAM): Active registration, renewed annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Unique Entity Identifier (UEI): Obtained through SAM.gov registration.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Applicants must have an active SAM registration to complete Grants.gov registration.

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources to carry out the proposed research.
Multiple PDs/PIs are allowed, following specific NIH policies.
All PDs/PIs must have an eRA Commons account, affiliated with the applicant organization.

Cost Sharing

Cost sharing is not required.

Application Process

Application Process Steps

Access application package: Through NIH ASSIST system, institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Submission: Electronically via Grants.gov, then track status in eRA Commons.
Required registrations: SAM (System for Award Management), UEI (Unique Entity Identifier), eRA Commons, and Grants.gov must be active prior to submission. Registration can take 6 weeks or more.

Application Deadlines

Latest New Application Due Date: February 16, 2026
Latest Renewal/Resubmission/Revision Due Date: June 16, 2026
All applications are due by 5:00 PM local time of applicant organization.
If a due date falls on a weekend or Federal holiday, the deadline extends to the next business day.
It is encouraged to apply early to allow time for error correction.

Required Documentation and Materials

Research (R) Instructions from 'How to Apply - Application Guide' must be followed, with program-specific instructions taking precedence.
SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget forms.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: Must include Research Strategy (Significance, Innovation, Approach), Resource Sharing Plan, and Other Plan(s).
Data Management and Sharing Plan: Required for all applications generating scientific data, regardless of direct costs. Expected to share data via NIMH Data Archive (NDA) semi-annually (January 15 and July 15 for descriptive/raw data, at publication or grant end for other data).
Appendix: Limited to blank questionnaires or blank surveys.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved, including Study Record or Delayed Onset Study.
PHS Assignment Request Form.

Submission Format and Platform

Electronic submission only; paper applications are not accepted.
Errors must be corrected and a changed/corrected application resubmitted by the due date.

Evaluation and Selection Process

Applications evaluated for scientific and technical merit by Scientific Review Groups.
Written critique provided for all applications.
High-merit applications (generally top half) will be discussed and receive an overall impact score.
Funding decisions consider scientific merit, fund availability, and relevance to program priorities.

Post-Application Requirements

Just-in-Time information may be requested if the application is under consideration for funding.
NIH reviews federal award history in SAM.gov for sound business practices.

Application Assistance

eRA Service Desk for technical issues with ASSIST, eRA Commons, application errors.
NIH General Grants Information for application instructions and processes.
Grants.gov Customer Support for registration and Workspace issues.
Scientific/Research Contacts and Financial/Grants Management Contacts are available for inquiries specific to the NOFO.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through the NIH peer review system, with an overall impact score. Scored Review Criteria These factors receive a separate criterion score and contribute to the overall impact score: - Factor 1. Importance of the Research (Significance and Innovation): - Significance: Potential to link mechanisms/risk factors to NPS across levels of analysis; clarify neurobiological/behavioral mechanisms of NPS in AD/ADRD. - Innovation: Extent to which the proposed paradigm, model, or assay significantly advances scientific knowledge toward linking mechanisms/risk factors to NPS; integration of multiple levels of analysis regarding dynamic relationships between NPS symptoms and AD pathogenesis. - Factor 2. Rigor and Feasibility (Approach): - Appropriate theoretical justification for the proposed approach. - For imaging studies: Examination of neural circuits in NPS in AD/ADRD compared to other neuropsychiatric diseases. - For animal studies: Well-validated models of circuitry involved in NPS and corresponding validated behavioral assays. - Factor 3. Expertise and Resources (Investigator(s) and Environment): - Qualifications and experience of the research team. - Adequacy of the scientific environment and resources to conduct the proposed research. Additional Review Criteria (considered, but not scored)

Protections for Human Subjects: Evaluation of plans for human subject research safety and ethics.
Vertebrate Animals: Justification for animal use, minimization of discomfort, and euthanasia methods if applicable.
Biohazards: Assessment of safety measures for hazardous materials/procedures.
Resubmissions: Evaluation of the entire application as presented.
Revisions: Appropriateness of proposed expansion of project scope.

Additional Review Considerations

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to proposed research.
Scientific and Technical Merit: As determined by peer review.
Availability of Funds: Contingent on NIH appropriations.
Relevance to Program Priorities: Alignment with NIMH and NIA specific research interests.

Compliance & Special Requirements

Regulatory Compliance

All NIH awards are subject to NIH Grants Policy Statement terms and conditions, cost principles, and federal regulations (e.g., 2 CFR Part 200).
Mandatory disclosure of federal criminal law violations related to fraud, bribery, or gratuity.
Nondiscrimination laws apply; recipients must submit an Assurance of Compliance (HHS-690).

Data Protection and Privacy

Data Management and Sharing Plan required: Scientific data generated must be shared via the National Institute of Mental Health Data Archive (NDA), adhering to specific submission schedules (semi-annually for descriptive/raw data, at publication or grant end for other data).
Common Data Elements (CDEs): NIMH expects investigators to collect CDEs for mental health human subjects research and include associated costs in the budget.

Ethical Standards & Human/Animal Subjects

Human Subjects: Research involving human subjects must comply with NIH policies and federal regulations, including IRB/IEC approval, data and safety monitoring plans, and ClinicalTrials.gov registration and results reporting for applicable clinical trials.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements: Applicable for clinical research involving investigational therapeutics, vaccines, or medical interventions.
Vertebrate Animals: Compliance with animal welfare regulations and guidelines if proposed research includes animals.

Technical and Operational Requirements

Intergovernmental Review (E.O. 12372): This initiative is not subject to intergovernmental review.
Genomic Data Sharing Plans: Implementation changes for applications due on or after January 25, 2023.
Rigor and Transparency: Strongly encouraged to incorporate principles from NOT-OD-15-103 on enhancing reproducibility, and NIMH guidelines for reporting rigor in experimental design.
Research Domain Criteria (RDoC): Encouraged to use constructs from NIMH's RDoC initiative or RDoC-compatible approaches for assessing NPS.
Human Connectome Project Protocols: Encouraged for neuroimaging methods if research addresses relevant constructs.
Academic-Industry Collaborations: NIA strongly encourages applications developed through these partnerships.
Data Annotation and Curation: Applicants expected to support annotation and curation of molecular and clinical data for usability by the broader research community.

Risk Management and Security

NIH may terminate awards under certain circumstances (2 CFR Part 200.340 and NIH Grants Policy Statement).

Special Considerations

Mechanistic Clinical Trials: This NOFO will support mechanistic clinical trials aimed at understanding biological/behavioral processes or intervention mechanisms of action.
Exclusions: Will not support studies solely focused on evaluating safety, clinical efficacy, effectiveness, management, or implementation of new interventions.
Innovation: R21 mechanism supports novel scientific ideas, new model systems, tools, or technologies with potential for significant impact, requiring less preliminary data.
Target populations: Emphasis on understanding NPS in persons with AD/ADRD, including diverse ethnic and racial backgrounds and sex differences.
Unmet Needs: Research to establish underlying causes for NPS resulting from 'unmet needs' (e.g., pain, boredom) and develop screening/handling methods.

Grant Details