Technology to Detect, Monitor and Assess Daily Functions in Individuals with Cognitive Decline, Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD) (R41/R42 Clinical Trial Not Allowed) | PAR 18 326

FAQs: Technology to Detect, Monitor and Assess Daily Functions in Individuals with Cognitive Decline, Alzheimer's Disease and/or AD/ADRD (R41/R42, Clinical Trial Not Allowed)

1) What is the main purpose of this funding opportunity?

This NIH STTR opportunity supports the research and development of practical technologies that measure real-world, day-to-day functioning in people at risk for, or living with, Alzheimer's disease and/or Alzheimer's disease related dementias (AD/ADRD). The central idea is to use continuous or near-continuous data from everyday life to provide a clearer, more objective picture of functional change than occasional clinic visits or one-time assessments.

2) What kinds of technologies is the program looking for?

The announcement encourages wearable devices, mobile-based tools, and other technology platforms, including software applications, that can collect ongoing information related to activities of daily living. The emphasis is on practical tools that can work in real-world settings and track function over time with minimal user burden.

3) What types of daily functioning data or behaviors are in scope?

Examples mentioned include patterns and changes in routine behaviors such as movement, sleep, location and wandering risk, medication-taking behaviors, communication and phone use, computer interaction, meal preparation habits, and social engagement. More broadly, the focus is on indicators that reflect independence and functional abilities.

4) Why does the FOA emphasize continuous or near-continuous monitoring?

Continuous, real-world monitoring is highlighted because it can help detect subtle shifts early, track progression over time, and provide longitudinal, objective information that may be useful to researchers, clinicians, caregivers, and healthcare providers. The approach is intended to complement or improve upon snapshots from infrequent assessments.

5) Is the program focused on passive monitoring or active user input?

The FOA signals strong interest in passive or low-effort monitoring approaches that reduce burden on participants, older adults, and caregivers. While it does not exclude other approaches, it underscores minimal burden and real-world usability.

6) Who is eligible to apply?

Eligibility is limited to small businesses under the STTR mechanism. The program is structured for small business-led teams working in partnership with a research institution.

7) Do applicants need to partner with a research institution?

Yes. Because this is an STTR opportunity, it is intended for small businesses that partner with a research institution, combining commercialization capacity with scientific expertise.

8) What award mechanism does this opportunity use?

The FOA uses the STTR R41/R42 mechanism. This aligns with a phased approach: an early-stage phase focused on feasibility and prototype development (R41), followed by a more advanced phase focused on further development and validation (R42).

9) Are clinical trials allowed under this announcement?

No. The announcement explicitly states "Clinical Trial Not Allowed." This generally means the application should not propose studies that meet NIH's definition of a clinical trial (for example, prospectively assigning human participants to an intervention to evaluate health-related outcomes).

10) Can the proposed work still involve human participants?

Yes. The FOA indicates that work may include human-centered design, usability testing, observational data collection, and technology validation studies, as long as the proposed research does not cross into an NIH-defined clinical trial.

11) What kinds of studies are typically acceptable given "Clinical Trial Not Allowed"?

Based on the description provided, acceptable activities can include usability testing, observational monitoring, and validation efforts that assess technology performance and data quality without prospectively assigning participants to an intervention for evaluating health-related outcomes.

12) Are foreign organizations eligible to apply?

No. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this announcement.

13) Are any foreign components allowed at all?

The notice indicates that foreign components (as defined by the NIH Grants Policy Statement) may be allowed in some circumstances. This usually means certain aspects of the work might occur outside the U.S. with strong justification and in compliance with NIH policy, but the applicant organization itself must be an eligible U.S.-based small business.

14) What is the funding opportunity number?

The funding opportunity number is PAR 18 326.

15) What agency and program area sponsor this opportunity?

This is offered by the National Institutes of Health (NIH) as a discretionary grant in the health area. The listing references CFDA 93.866.

16) What is the maximum award amount shown for this opportunity?

The record shows an award ceiling of $350,000.

17) What is the closing date listed in the opportunity record?

The original closing date listed is 2020-01-05.

18) Is this opportunity likely historical based on the dates shown?

The record shows it was created on 2017-10-25 and lists a closing date of 2020-01-05, which suggests this specific posting may be historical. However, the priorities described align with broader NIH and NIA interests in digital health, passive sensing, and functional outcome measurement in dementia research.

19) What kinds of outcomes or benefits are these tools expected to support?

The FOA frames these technologies as potentially supporting earlier detection of functional change, tracking disease progression, and providing objective longitudinal information that could assist research, clinical monitoring, or care planning, while keeping user burden low.

20) What design and implementation considerations appear important for competitive projects?

The description highlights technical innovation, reliable and interpretable measurements, user acceptability for older adults and caregivers, data quality, data security considerations, and a credible path toward translating a prototype into a deployable product, without proposing an NIH-defined clinical trial.

21) What populations are the focus of measurement and monitoring?

The focus is on individuals who are at risk for, or already living with, cognitive decline, Alzheimer's disease, and/or AD/ADRD, with measurement centered on daily function and independence-related behaviors.

22) What is meant by "daily functions" in this context?

In this FOA, "daily functions" refers to practical, everyday activities and behaviors that reflect independence and functional abilities. Examples provided include movement and routine activity patterns, sleep, location and wandering risk, medication-taking behaviors, communication and technology use, meal preparation habits, and social engagement.