Enhancing NIA’s Alzheimer’s clinical trials pipeline
January 13, 2022

Kristina MCLINDEN,
Program Director,
Division of Neuroscience (DN).

My colleagues and I often hear from investigators who have an intervention that has demonstrated efficacy in treating another disease or disorder, such as attention deficit/hyperactivity disorder in children, that they believe might be repurposed to treat age-related cognitive decline or Alzheimer’s and related dementias. But it can be difficult for these scientists to break into a new (for them) field of research. Another big hurdle is the lack of seed money to fund their collection of persuasive preliminary data for future studies.

How can these researchers get their foot in the door and compete for an R01? While we referred them to parent R21 grants in the past, this activity code wasn’t the best fit for their situations. To help investigators overcome these obstacles, we’re pleased to announce a new funding opportunity (FOA) designed specifically to help researchers new to the fields of age-related cognitive decline and Alzheimer’s and related dementias gather persuasive preliminary data in support of clinical trials and to facilitate a successful R01 submission.

Bridging the early-stage data gap

If you have an idea for an intervention but need funding to gather preliminary data, or if you have preliminary data from another population or disease area and wish to move into aging neuroscience, then this is the FOA for you!

Our new FOA invites applications for projects to collect pilot data to support early-stage (phase I-II) clinical trials and related human and/or animal testing of promising interventions for these diseases. It is designed for studies that target presymptomatic to more severe stages of disease and also aims to stimulate studies to enhance clinical trial design and methods.

This FOA was developed using the R61 activity code. The goal of the R61 is to function similarly to the R21, with a maximum project period of two years, but the budget for R61 pilot clinical trials is larger: up to $325,000 in direct costs per year.

Moving forward: Next steps for promising interventions

While you’re looking into if the new R61 is a good fit for you, here are two other Alzheimer’s and related dementias and age-related cognitive decline FOAs that might be of interest. These are, however, focused on later clinical trials and phases:

• PAR-21-359: Early-Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)
• PAR-20-309: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

Be prepared to share data

If you are successful in your application for any of these FOAs, be prepared to share your data! Sharing clinical trial data and biosamples is expected at the time of publication of the primary results or within nine months of database lock, whichever comes first. Your application must include a data sharing plan. Reach out if you have any questions about how best to share your data.

Apply now for a chance to move your ideas forward!

Please read the listed application dates carefully before you apply to any NIA FOA. Apply now for the R61 ahead of the March 4, 2022, deadline, and please note the nonstandard due dates for the first submission cycle. Email me with any questions — I look forward to hearing more about your ideas for innovative interventions and wish you best of luck in your applications!