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Grant Analysis

Purpose & Target

Objective: To streamline the early-stage clinical evaluation of promising pharmacological interventions for Alzheimer's Disease (AD) and AD-related Dementias (ADRD) by bundling Phase 1 and Phase 1b/2a clinical trials.
Target Recipient: Organizations and researchers engaged in biomedical, social, and behavioral research, specifically focusing on drug development for AD/ADRD.
SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on healthcare, pharmaceutical development, and clinical research within neurodegenerative diseases.
Geographic Scope: Worldwide, accepting applications from U.S. and non-U.S. entities (foreign organizations).
Key Filtering Criteria: Clinical trial is required. Interventions must engage non-amyloid/non-tau mechanisms and address cognitive/neuropsychiatric symptoms across disease stages. Must include both Phase 1 (UG3) and Phase 1b/2a (UH3) activities. Definitive efficacy trials (Phase 3) are not supported.
Grant Frequency and Program Context: This is a recurring funding opportunity (reissue of PAR-23-274) with multiple application cycles, part of the National Institute on Aging's (NIA) ongoing efforts under the National Alzheimer's Project Act (NAPA) to accelerate AD/ADRD research and treatment development.

Financial Structure

Budget range: Application budgets are not limited, but they must reflect the actual needs of the proposed project.
Eligible costs: Not exhaustively detailed, but typical clinical trial costs are implied, such as Good Laboratory Practice (GLP) toxicology studies, Good Manufacturing Practice (GMP) for drug substance/product, regulatory approvals, and acquisition/analysis of biomarkers.
Matching fund requirements: No cost sharing is required for this funding opportunity.
Payment schedule and mechanisms: Not explicitly stated beyond the 'phased award' mechanism (UG3/UH3), where transition to the UH3 phase depends on successfully reaching agreed-upon milestones and 'go/no-go' criteria.
Financial reporting requirements: Recipients are required to submit annual financial statements as part of the Research Performance Progress Report (RPPR) and a final expenditure data portion for closeout.
Indirect cost policies: Not explicitly detailed, but NIH grants policies (including indirect cost policies) apply.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Eligibility Requirements

Organization Type

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With or without 501(c)(3) IRS Status (other than institutions of higher education).
For-Profit Organizations: Small Businesses, Other For-Profit Organizations.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and 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, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Project Requirements

Clinical trial is required. Projects must propose clinical trial(s).
Applications must bundle independent protocols for Phase 1 (UG3) and Phase 1b/Phase 2a (UH3) clinical trials in a single application.
Candidate interventions must engage non-amyloid/non-tau mechanisms.
Candidate interventions must aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum of AD/ADRD (pre-symptomatic to severe stages).
Non-Responsive Criteria (applications will be withdrawn prior to review):
- Applications to implement definitive efficacy trials (e.g., Phase 3 trials of drugs/biologics or pivotal trials).
- Applications that only propose UG3 or UH3 activities (must propose both as a bundled, phased award).

Registration Requirements

Applicant organizations must complete and maintain active registrations prior to application submission (can take 6 weeks or more):
- System for Award Management (SAM) - requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code - for foreign organizations, in lieu of a CAGE code.
- Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
- eRA Commons - requires at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - requires active SAM registration.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account affiliated with the applicant organization.

General Criteria

Cost sharing is not required.
Applicant organizations may submit more than one application, provided each application is scientifically distinct.
Duplicate or highly overlapping applications are not accepted under review at the same time.

Application Process

Application Submission Dates

Open Date (Earliest Submission Date): January 21, 2025
Letter of Intent Due Date(s): January 21, 2025 (not required, not binding).
Application Due Dates (multiple cycles, latest for new applications):
- New, Renewal, Resubmission, Revision: October 19, 2026 by 5:00 PM local time of applicant organization.
Expiration Date: November 20, 2026.

Application Submission Process

Applications must be submitted electronically through:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Required registrations (SAM, NCAGE for foreign organizations, UEI, eRA Commons, Grants.gov) must be completed prior to application submission. Registration can take 6 weeks or more.
Applicants must follow the instructions in the 'Research (R) Instructions' in the 'How to Apply - Application Guide', except where explicitly instructed otherwise by this funding opportunity (NOFO).
Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks before submitting the application.
Applicants are encouraged to apply early to allow time for corrections.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Required Documentation and Materials

Standard application forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, with additional specific instructions:
- Specific Aims: Must describe specific aims for both UG3 and UH3 phases on a single attachment with separate headers.
- Research Strategy: Details on UG3 (Phase 1/1a studies) and UH3 (Phase 1b/2a studies), including mechanism of action, target's role, optimal disease stage, go/no-go milestones, and safety evidence.
- Significance and Biological Relevance: How the trial will test hypotheses, advance the field, future clinical development plans, and improvement over existing therapies.
- Preliminary Studies: Major findings from preclinical and clinical studies, adherence to NIH scientific rigor guidelines.
- Approach: Rationale for trial design, population, hypotheses, controls, addressing biases/challenges, assessment of outcomes, heterogeneous participants, timely data/biosample access, rigor/transparency.
Letters of Support: Include a page listing names and institutions of all providers. Document any non-NIH trial support if available.
Resource Sharing Plan: Must address which biosamples will be shared, where they will be stored, and how approved parties will access them. Biosamples must be available at publication or within 9 months of database lock.
Data Management and Sharing Plan: Required for all applications generating scientific data. Must describe methods for data collection, quality control, confidentiality, privacy, data storage, and access. Sharing of clinical trial data (participant-level and summary-level) expected at publication or within 9 months of database lock.
Appendix: Limited to blank questionnaires or blank surveys only; no publications or other material.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved. Includes:
- Study Record: Study Population Characteristics (inclusion of women/minorities, translation of documents).
- Study Timeline: Detailed performance and timeline objectives, clear/quantitative milestones for UG3/UH3.
- Protection and Monitoring Plans: Data and Safety Monitoring Plan (referencing NIA's guidelines) and study team structure (advisory committees).
PHS Assignment Request Form.

Post-Award Requirements and Reporting Obligations

Annual Research Performance Progress Report (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for award closeout.
ClinicalTrials.gov registration and results reporting are expected for all trials.
NIA utilizes the Clinical Research Operations & Management System (CROMS); grantees active as of July 1, 2021, and supporting human subjects research, must interact with and use CROMS.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
Factor 2: Rigor and Feasibility (Approach)
Factor 3: Expertise and Resources (Investigator(s) and Environment)

Additional Review Criteria (not scored, but considered for overall impact)

Protections for Human Subjects
Vertebrate Animals
Biohazards
Resubmissions, Renewals, Revisions (as applicable)

Additional Review Considerations (not scored, not for overall impact)

Authentication of Key Biological and/or Chemical Resources
Budget and Period of Support

Project Specific Scoring Factors

Proposed milestones must be clear and quantitative, with achievable goals for each stage of the UG3/UH3 project.
Presence of prespecified 'go/no-go' safety and tolerability milestones for advancing from Phase 1 (UG3) to later stages (UH3).
Evidence of safety from earlier clinical trials (if applicable) and further safety evaluation in the proposed trial design.
Phase 2a clinical trials must be designed as 'proof of mechanism/target engagement/proof of concept' studies.
Demonstrated significance of the proposed Phase 1 and Phase 2 clinical trials in the context of disease therapeutics, and how results will advance the field.
Clear summary of plans for future clinical development and justification for the necessity of the exploratory trial.
Description of how the proposed intervention will likely be an improvement over existing therapies.
Preliminary studies must detail major findings, meet NIH scientific rigor guidelines, and address identified gaps.
Research plan must describe rationale for trial design, population(s), hypotheses, and control groups, addressing potential biases/challenges.
Study design must enable rigorous assessment of outcomes (safety, tolerability, dosing, target engagement, etc.).
Inclusion of heterogeneous participants within trial cohorts.
Timely access to trial data and associated biosamples for the broader research community.
Adherence to NIH's guidance for rigor and transparency in grant applications (e.g., clear endpoints, blinding, randomization, appropriate sample size, handling missing data, preplanning analyses).

Compliance & Special Requirements

Regulatory Compliance

Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Adherence to the NIH Grants Policy Statement.
Compliance with all applicable nondiscrimination laws, including submission of an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, as highlighted in NIH Grants Policy Statement Section 4.
If funding involves implementing, acquiring, or upgrading health IT, recipients must use IT that meets standards in 45 CFR part 170, Subpart B, or is certified under the ONC Health IT Certification Program (if for eligible clinicians).
Clinical research involving investigational therapeutics, vaccines, or medical interventions must be performed under an FDA investigational new drug (IND) or investigational device exemption (IDE).

Data Protection and Security

When recipients have ongoing access to HHS information/operational technology systems or handle PII/PHI obtained from HHS, they must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards and Oversight

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols involving human subjects.
Recipients must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Adherence to NIH policy for data and safety monitoring for human biomedical and behavioral intervention studies.
Informed Consent Documents (ICD) must list 'The National Institutes of Health (NIH) and its authorized representatives' as entities that may access study records.
Plans for inclusion of women and racial/ethnic minorities in studies, including translation of study documents, are required.

Intellectual Property Policies

Recipients retain custody of and primary rights to data and software developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.

Special Programmatic Aspects (Cooperative Agreement)

This funding instrument is a 'Cooperative Agreement,' which signifies substantial Federal scientific or programmatic involvement from NIH (specifically NIA).
NIH staff (e.g., NIA Project Scientist) will provide technical assistance, advice, and coordination, and participate in monitoring recruitment, quality assurance/control, and protocol adherence.
The NIA program official will assess progress and recommend funding levels.
A Dispute Resolution Panel composed of three members (recipient designee, NIH designee, and a third expert) is established to resolve scientific or programmatic disagreements.

Grant Details