This grant supports the pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates for Alzheimer’s disease (AD). The objective is to fund therapies that prevent AD, slow its progression, or treat cognitive and behavioral symptoms. Supported activities include medicinal chemistry, pharmacokinetics (PK), ADMET, animal efficacy, biomarker development, formulation, GMP synthesis, Investigational New Drug (IND) enabling studies, and initial Phase I clinical testing. This program focuses on accelerating promising AD drug candidates towards early human trials.
Opportunity ID: 355120
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-223 |
| Funding Opportunity Title: | Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.866 — Aging Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 25, 2024 |
| Last Updated Date: | Dec 04, 2024 |
| Original Closing Date for Applications: | Nov 05, 2027 |
| Current Closing Date for Applications: | Dec 03, 2024 |
| Archive Date: | Jan 02, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities City or township governments State governments County governments For profit organizations other than small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer’s disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-223.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date per reissued NOFO PAR-25-297. | Dec 04, 2024 | |
| Jun 25, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-223 |
| Funding Opportunity Title: | Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.866 — Aging Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 25, 2024 |
| Last Updated Date: | Dec 04, 2024 |
| Original Closing Date for Applications: | Nov 05, 2027 |
| Current Closing Date for Applications: | Dec 03, 2024 |
| Archive Date: | Jan 02, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities City or township governments State governments County governments For profit organizations other than small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer’s disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-223.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-223 |
| Funding Opportunity Title: | Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.866 — Aging Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 25, 2024 |
| Last Updated Date: | Jun 25, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 05, 2027 |
| Archive Date: | Dec 11, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Private institutions of higher education City or township governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State governments For profit organizations other than small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer’s disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-223.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
Folder 355120 Full Announcement-PAR-24-223 -> PAR-24-223-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288346 | Jan 03, 2025 | Jan 03, 2025 | View |
Package 1
Mandatory forms
355120 RR_SF424_5_0-5.0.pdf
355120 PHS398_CoverPageSupplement_5_0-5.0.pdf
355120 RR_OtherProjectInfo_1_4-1.4.pdf
355120 PerformanceSite_4_0-4.0.pdf
355120 RR_KeyPersonExpanded_4_0-4.0.pdf
355120 PHS398_ResearchPlan_5_0-5.0.pdf
355120 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
355120 RR_Budget_3_0-3.0.pdf
355120 RR_SubawardBudget30_3_0-3.0.pdf
355120 PHS398_ModularBudget_1_2-1.2.pdf
355120 PHS_AssignmentRequestForm_4_0-4.0.pdf
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