Sensory and motor system changes as predictors of preclinical Alzheimers disease (R01 - Clinical Trial Not Allowed) | PAR 18 519

Frequently Asked Questions (FAQs) - NIH PAR-18-519 (R01)

1) What is the main purpose of this NIH funding opportunity (PAR-18-519)?

This NIH opportunity supports R01 research projects that examine whether changes in sensory and/or motor systems can serve as early indicators of Alzheimer's disease, particularly during the preclinical stage when typical cognitive symptoms may not yet be apparent.

2) What is the central scientific idea behind the program?

The core idea is that measurable changes in functions such as vision, hearing, smell, balance, gait, coordination, strength, or other motor outputs may track underlying Alzheimer's-related biology. These changes may help predict who is on a trajectory toward Alzheimer's disease, how quickly progression might occur, and how sensory/motor changes relate to the broader disease process.

3) What kinds of sensory and motor functions are in scope?

The FOA describes a broad range of sensory and motor domains, including (but not limited to) vision, hearing, smell, balance, gait, coordination, strength, and other motor outputs, as potential early markers or mechanistic readouts related to Alzheimer's disease.

4) Is the focus only on clinical (human) research?

No. The FOA welcomes basic research, clinical research, and integrated basic-clinical programs. Studies may involve older adult human participants and/or animal models, depending on the research question.

5) What types of study designs does the FOA encourage?

The announcement is deliberately broad and invites a wide range of study types, including basic, clinical, or integrated approaches. For clinical research, it signals a strong preference for leveraging existing longitudinal cohorts that already collect sensory and motor assessments.

6) Why does the FOA emphasize existing longitudinal cohorts for clinical research?

Using existing longitudinal cohorts can speed discovery by relying on established datasets, repeated measures over time, and well-characterized participants. Longitudinal designs are well-suited to test whether sensory/motor changes occur before cognitive decline, whether they predict conversion to mild cognitive impairment or dementia, and how they interact with known risk factors and biomarkers.

7) What methods and tools can applicants use?

The FOA encourages investigators to use the tools that best fit the mechanism or biomarker pathway under study. Examples mentioned include cellular and molecular assays, genetics, imaging approaches, physiological measurements, and other experimental strategies.

8) What are examples of research directions that fit this FOA?

Examples described in the opportunity include: studying neural circuitry and synaptic changes that affect motor control; imaging studies linking sensory decline to brain network changes; and genetic or molecular studies tying sensory/motor phenotypes to Alzheimer's-related pathology.

9) What NIH grant mechanism is used for this opportunity?

The award mechanism is an NIH Research Project Grant (R01).

10) Are clinical trials allowed under this FOA?

No. The FOA is labeled "Clinical Trial Not Allowed," meaning the supported work should not be designed as a clinical trial that prospectively assigns human participants to an intervention to evaluate its effect on health-related outcomes.

11) Are human clinical studies allowed if they are not clinical trials?

Yes. The FOA allows clinical studies and observational human research, as long as the project is not an interventional clinical trial as defined by NIH (i.e., no prospective assignment to an intervention to assess health-related outcomes).

12) Can applicants use animal models?

Yes. The FOA states that applicants may use animal models and/or older adult human participants, depending on the scientific question being asked.

13) Who is eligible to apply?

Eligibility is broad and includes many U.S. organization types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

14) Are specific institution types highlighted as eligible?

Yes. The FOA highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and U.S. territories or possessions.

15) Can foreign institutions apply directly?

No. Foreign institutions are not eligible to apply directly under this opportunity.

16) Can a U.S. organization include non-U.S. components?

No. Non-U.S. components of U.S. organizations are not eligible under this FOA.

17) Are any foreign elements allowed at all?

Yes. The FOA indicates that foreign components (as defined by NIH policy) may be included when appropriately justified, even though foreign institutions cannot apply directly and non-U.S. components of U.S. organizations are not eligible.

18) Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

19) What is the Assistance Listing (CFDA) number associated with this opportunity?

The CFDA/Assistance Listing number provided is 93.866.

20) What category does this activity fall under?

The activity falls under the health category.

21) What is the deadline shown in the provided record?

The original closing date listed is November 6, 2020. Based on the information provided, this indicates the record reflects an older deadline rather than a newly posted closing date, even though the scientific scope still provides a clear snapshot of NIH priorities described in the opportunity.

22) What stage of Alzheimer's disease is especially emphasized?

The FOA especially emphasizes the preclinical stage, when classic cognitive symptoms may not yet be obvious, and aims to understand whether sensory and motor changes can serve as early indicators during that period.

23) What outcomes or relationships are projects expected to explore?

Projects are positioned to explore whether sensory/motor changes can: predict who is on a path toward Alzheimer's disease; indicate how quickly progression might occur; and clarify how these changes relate to underlying disease biology and the broader Alzheimer's disease process.