Get the inside scoop on ACTC applications!
We’re looking forward to receiving the next round of applications for trials that will be supported by the recently launched Alzheimer’s Clinical Trial Consortium (ACTC). This new cooperative agreement was awarded in December, and the new funding opportunity announcement for ACTC trials published shortly afterwards. The next submission date is June 5. If you haven’t started thinking about conducting a trial using the ACTC infrastructure, don’t panic! There are three submission dates per year and the next deadline is in October.
To help you through the application process for this new consortium, we’ve created a webpage with tips and FAQs. Here are some highlights:
Step 1: Contact us
We strongly encourage you to contact one of us (Laurie Ryan or Kristina McLinden) in the early planning phases of any study to discuss the feasibility of conducting a trial through the ACTC infrastructure. As mentioned in an earlier blog post, the ACTC is a “next-generation” infrastructure designed to harness best practices and latest methods to address the timeframe, complexity, and expense of recruitment and site activation for Alzheimer’s trials. We’re looking for applications to develop and implement multisite Phase I to III clinical trials that would use the ACTC expertise, coordination, and management infrastructure.
Step 2: Contact ACTC
Applicants must submit an ACTC Clinical Study Concept Proposal. Make sure this proposal includes the specific aims for the study, relevant preliminary data, and study design. The proposal will be reviewed first by the Protocol Evaluation Committee, and if allowed to move forward, will be voted on by the ACTC Steering Committee. The ACTC program administrator is Sarah Walter. Please note that approval by the ACTC Steering Committee does not guarantee NIA funding.
Step 3: Apply to the FOA
If your proposal is approved by the ACTC Steering Committee, you may then formally apply to the ACTC R01 Funding Opportunity Announcement (PAR-18-513) with help from the ACTC Coordinating Center. Your application will then undergo NIH peer review and will receive an impact score. Applications will be funded based on score and NIA funding priorities. We expect to fund five to seven trials during the five-year award period.
Other key considerations
While ACTC has 35 sites, not every study will use all the sites. The number and choice of sites should be tailored to the specific project being proposed. You may also propose additional sites if there is scientific or practical rationale for doing so.
Be prepared to share your data through the ACTC. Sharing of 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 should include a data sharing plan.
ACTC is certainly not the only NIA clinical trial funding opportunity. We have a long-standing history of funding pharmacological and non-pharmacological Alzheimer’s clinical trials through several other means and will continue to do so. For example:
- Pilot Clinical Trials for the Spectrum of Alzheimer’s Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) (PAR-18-175)
- Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required) (PAR-18-028)
The bottom line: We’re here to help and hope to hear from you soon.