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Applicant Resources for Mechanism-Focused Research to Promote Adherence to Healthful Behaviors to Prevent Mild Cognitive Impairment (MCI) and Alzheimer’s Disease and Related Dementias (R61/R33, R01)

Funding Opportunities

RFA-AG-22-016: Mechanism-Focused Research to Promote Adherence to Healthful Behaviors to Prevent Mild Cognitive Impairment (MCI) and Alzheimer’s Disease and Related Dementias (AD/ADRD) (R61/R33 Clinical Trial Required)

PAR-21-207: Mechanism-Focused Research to Promote Adherence to Healthful Behaviors to Prevent Mild Cognitive Impairment (MCI) and Alzheimer’s Disease and Related Dementias (AD/ADRD) (R01 Clinical Trial Optional)

Pre-Recorded FOA Guidance

FAQs

What is the overall goal of these FOAs?

The ultimate goal of these FOAs is to identify meaningful (e.g., causal), modifiable factors that promote adherence to lifestyle changes or to other (e.g., cognitive training) behaviors that hold potential for prevention of cognitive decline, MCI, and AD/ADRD. Specifically, this will be done by conducting research to understand how, why, and for whom particular features of behavior change interventions engage specific psychological or interpersonal processes that promote maintenance of (adherence to) health behaviors.

Should the application focus only on Alzheimer’s disease?

Not necessarily. We want to understand adherence to lifestyle changes or to other (e.g., cognitive training) behaviors that hold potential for prevention of cognitive decline, MCI, and AD/ADRD across a variety of dementia subtypes including Alzheimer’s, vascular, Lewy body, and frontotemporal dementias.

Does the application need to include individuals with diagnosed MCI or AD/ADRD?

Not necessarily. Special attention needs to be paid to particular adherence challenges among high-risk individuals in midlife, including individuals with family history of AD/ADRD, those with predisposing risk factors, and those in health disparities populations known to be at greater risk for AD/ADRD, but it is not a requirement to study individuals with diagnosed MCI or AD/ADRD. Applications should be grounded in evidence that the behavioral or lifestyle change under study has potential for preventing cognitive decline, MCI, and AD/ADRD.

Am I required to include a health disparities focus in my application?

NIA encourages applications that focus on individuals in midlife who are at greater risk for AD/ADRD, including health disparities populations, but this is not a requirement.

Is the focus of this FOA on adherence, AD/ADRD prevention, or both?

Research projects developed through this FOA should focus on adherence outcomes (i.e., measures of sustained engagement and/or repeated re-engagement in lifestyle or behavior change). Achieving such adherence will be essential to any long-term public health efforts to prevent AD/ADRD. Measures of cognitive function, AD/ADRD risk factors, and relevant AD/ADRD cognitive or functional outcomes should be included in the study and may provide important preliminary data for future studies. This FOA is not intended to support the development of primary AD/ADRD prevention trials.

Is my application required to follow the NIH Stage Model for Behavioral Intervention Development framework?

Yes.

How do I learn more about the NIH Stage Model?

View the Stage Model for Behavioral Intervention Development page.

Is my application required to use the Science of Behavior Change (SOBC) program methods and measures?

No, the SOBC program methods and measures are a research resource and example for how to design and conduct mechanisms-focused research, which is a requirement for this FOA. Applications are not required to use specific SOBC targets (mechanisms) and measures. Applications are encouraged to consider individual-level or interpersonal factors that impact adherence to lifestyle changes, operate as moderators of the effectiveness of a behavior change intervention via effects on adherence, and/or inform tailoring approaches to promote adherence in specific populations over time. Such applications are encouraged to consider adherence-relevant behavioral phenotypes, mechanisms, or moderators of intervention effectiveness that operate at the individual and/or interpersonal level.

How do I learn more about the Science of Behavior Change (SOBC) program, methods, and measures?

View the Science of Behavior Change page.

View the "What is SOBC?" page.

View "The Measures" SOBC page.

Is a letter of intent required?

A letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, but the information that it contains allows staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Luke Stoeckel, Ph.D.
National Institute on Aging (NIA)
Telephone: 202-570-9388
Email: NIAAdherenceFOAs@mail.nih.gov

Are foreign institutes eligible?

Yes.

Are there special review criteria?

Yes. Please review Section V of the FOA carefully.

How should I decide whether to apply for the R61/R33 or R01?

The R61/R33 supports new pilot research (R61) to identify, measure, and assess the malleability of psychological or interpersonal adherence-relevant targets that, if successful, can transition to an R33 phase for implementation of rigorous, proof of concept intervention studies.

The R01 supports ancillary studies to ongoing early-to-late stage clinical intervention trials. Ancillary studies should provide the opportunity to explore novel psychological and interpersonal mechanisms by collecting new data from participants enrolled in the ongoing parent study.

Who do I contact if I have further questions?

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Luke Stoeckel, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: luke.stoeckel@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov

Specific to the R61/R33

How much funding will NIA allocate to the R61/R33 FOA?

NIA intends to commit $3 million in FY2022 to fund 6-8 awards.

What are the budgets for the R61 and R33 phases?

For the R61 planning phase, the budget for direct costs may not exceed $225,000.

For the R33 implementation phase, the budget for direct costs may not exceed $500,000 in any single year.

Application budgets need to reflect the actual needs of the proposed project.

Can unspent funds from the R61 phase carry over into the R33 phase?

No.

How does the R61/R33 work?

The R61/R33 is a 5-year phased award. The R61 pilot and planning phase (1-2 years) will establish the feasibility of identifying groups of participants at high risk for AD/ADRD and non-adherence to healthful behaviors that hold potential for prevention of cognitive decline, MCI, and AD/ADRD. This will also include Stage I research to create tailored adherence interventions for use in AD/ADRD prevention trials. If successful, projects can transition to an R33 phase (3-4 years) for implementation of Stage II-IV trials. The specific activities and milestones appropriate for the R61 phase will depend on the type of intervention and its stage of development.

The transition from the R61 to the R33 phase of the award will be administratively reviewed for and be dependent upon successful completion of the go/no-go criteria specified for the R61 phase.

Prospective applicants should note that funding of a grant application for the R61 phase does not guarantee support of the R33 phase. Transition to the R33 phase of the project will occur only if an administrative review process recommends that the R61 planning activities have been successful, the implementation phase of the project can proceed with confidence of success, and funds are available.

What should be included in the Milestone Plan and Transition Request?

The application must propose a well-defined set of milestones (see required milestones in the R61 phase section of the FOA) for the planning phase (R61) and annual milestones for the implementation phase (R33 phase section of the FOA). At the completion of the R61 planning phase, the applicant will be required to submit a detailed transition request for the R33 implementation phase. Specifically, the transition from the R61 to the R33 phase of the award will be administratively reviewed for successful completion of the go/no-go criteria that must be clearly specified in the R61 phase. Applicants can establish go/no-go criteria as they deem fit for their application, but must address each area as described in the FOA (R61 and R33 phase sections).

Do I submit a separate Research Plan for the R61 and R33 phases?

Separate specific aims should be presented for both the R61 and R33 phases on one page. The research strategy should contain separate sections that describe both the R61 and R33 phases. Separate research design and methods could be presented as needed for the R61 and R33 phases. It is not necessary to repeat information or details in the R33 section that are described in the R61 section.

Is preliminary data required?

Preliminary data are not required for an R61/R33 application. However, any preliminary data that will support or justify the proposed hypothesis, rationale, or development plan may be included.

Is my application responsive?

This FOA is NOT intended to fund the following:

  • Studies that do not include a primary focus on adherence, including adherence measures.
  • Studies not using a causal study design or experimental medicine approach to determine causal psychological or interpersonal mechanisms related to adherence.
  • Stand-alone adherence trials that do not focus on behaviors relevant to the prevention of AD/ADRD.
  • Trials designed to test the ability of a new intervention to promote adherence to behaviors relevant to AD/ADRD prevention in ongoing trials. Such applications should be routed through companion R01 FOA.
  • Non-human research studies.

Specific to the R01

What is an ancillary study?

A study that leverages existing or ongoing early-to-late stage (including Stages I-IV) clinical trials. Responsive applications will augment, refine, or adapt existing interventions that promote behaviors relevant to the prevention of cognitive decline, MCI, and AD/ADRD (e.g., cognitive training) by adding aims that target individual and interpersonal-level mechanisms of adherence. This FOA will support the integration of new, mechanistic approaches to inform the design and development of more effective, efficient, and personalized approaches to promote adherence to and maintenance of behavior changes for the prevention of AD/ADRD. This FOA is not intended to support only the inclusion of additional measures related to the parent study alone. Applications to this FOA must collect new data from participants enrolled in the ongoing parent study; this FOA is not intended to support secondary data analysis alone. This FOA may not be used to extend the duration of the parent study. Applications proposing to begin a new, stand-alone clinical trial are not appropriate for this R01 FOA and should be directed to the companion R61/R33 FOA.

Are clinical trials allowed?

Yes. An ancillary study will be considered a new clinical trial if it adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met (https://nexus.od.nih.gov/all/2019/01/08/is-my-ancillary-study-considered-a-clinical-trial/).

Do I need permission from the parent trial to apply to this FOA?

Applications to this FOA must include a letter from the appropriate committee (e.g., Ancillary Study Committee) or person (e.g., Chair of the Steering Committee) representing the parent study indicating that the parent study is willing to provide the ancillary study investigators with access to participants, data, and other necessary resources, as needed.

Can I submit an application to this FOA if the parent study has not started?

Ancillary study grant applications may be submitted to this FOA prior to the start of the parent study. However, the parent study must have started at the earliest award date for the ancillary study.

How much funding will NIA allocate to the R61/R33 FOA?

NIA intends to commit $2,250,000 in both FY2022 and FY2023 to fund 4-6 awards.

What is the budget and project period for this FOA?

Standard R01 budget and project period (maximum 5 years).

Application budgets need to reflect the actual needs of the proposed project.

Can funds be allocated to support the parent study?

No.

Is my application responsive?

Applications with the following characteristics are unresponsive to this FOA and will not be reviewed:

  • Studies that do not include a primary focus on adherence, including adherence measures
  • Studies not embedded within a clinical trial involving a behavior directly related to prevention of cognitive decline, MCI, and/or AD/ADRD
  • Studies not using an experimental medicine or novel analytic plan to determine causal psychological or interpersonal mechanisms related to adherence
  • Trials designed to test the ability of a new intervention to promote adherence to behaviors relevant to AD/ADRD prevention. Such applications should be routed through companion R61/R33 FOA
  • Studies focused on secondary data analysis alone
  • Non-human research studies