The National Institute on Aging offers this grant to foster partnerships between academics and wearable device companies. Its aim is to validate digital health technologies (DHTs) as monitoring biomarkers for Alzheimer’s Disease and Related Dementias (ADRD) populations. Projects must optimize DHTs in diverse, early-stage ADRD cohorts, demonstrating accuracy for clinically meaningful features like sleep stage. Studies should establish longitudinal links between measured features and quality-of-life metrics, correlating with validated ADRD biomarkers and cognitive assessments. The ultimate goal is to integrate these digital measures as monitoring biomarkers in future ADRD clinical trials, utilizing a phased R61/R33 mechanism.
Opportunity ID: 349714
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-026 |
| Funding Opportunity Title: | Validating digital health technologies for monitoring biomarkers in ADRD clinical trials (R61/R33 – Clinical Trials Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 02, 2023 |
| Last Updated Date: | Aug 02, 2023 |
| Original Closing Date for Applications: | Nov 17, 2023 |
| Current Closing Date for Applications: | Nov 17, 2023 |
| Archive Date: | Dec 23, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Special district governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Private institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments City or township governments |
| 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 not 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 RFA is to enable partnerships between academics and companies that make wearable devices to validate their digital health technologies (DHTs) as digital monitoring biomarkers in ADRD populations. Applications will be required to optimize their DHTs in diverse patient populations from two or more early stage clinically diagnosed ADRD. Studies must demonstrate the accuracy of the digital markers to differentiate clinically meaningful features (such as sleep stage) and establish the longitudinal relationship between the features measured with quality-of-life metrics. Studies should also establish the relationship with one or more analytically validated ADRD biomarker(s) and standard cognitive assessments to validate the relationship between the features measured by the DHTs with the underlying pathophysiology or cognitive concept it reflects. An ideal outcome would be evidence for incorporating these DHT measures as monitoring biomarkers in future ADRD clinical trials. A 5-year phased mechanism is requested with a 2-year start-up phase (R61) to ensure adequate community engagement and recruitment of diverse patient populations, and to conduct pilot studies to optimize the algorithms; this will be followed by a 3-year R33 validation phase. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-026.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 |
|---|---|---|
Related Documents
Folder 349714 Full Announcement-RFA-NS-24-026 -> RFA-NS-24-026-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-H | Use for due dates on or after January 25, 2023 | PKG00282771 | Oct 17, 2023 | Nov 17, 2023 | View |
Package 1
Mandatory forms
349714 RR_SF424_5_0-5.0.pdf
349714 PHS398_CoverPageSupplement_5_0-5.0.pdf
349714 RR_OtherProjectInfo_1_4-1.4.pdf
349714 PerformanceSite_4_0-4.0.pdf
349714 RR_KeyPersonExpanded_4_0-4.0.pdf
349714 RR_Budget10_3_0-3.0.pdf
349714 PHS398_ResearchPlan_5_0-5.0.pdf
349714 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
349714 RR_SubawardBudget10_30_3_0-3.0.pdf
349714 PHS_AssignmentRequestForm_3_0-3.0.pdf
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