A new era of clinical trials in Alzheimer's disease and related dementias
January 23, 2018

Laurie RYAN,
Chief, Clinical Interventions and Diagnostics Branch,
Division of Neuroscience (DN).

You may have already heard that the NIA has awarded a new cooperative agreement establishing the Alzheimer’s Clinical Trial Consortium (ACTC). We expect the ACTC to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias.

ACTC’s design allows rapid start-up of clinical trials and provides infrastructure and support in areas such as imaging, biostatistics, data management, and recruitment. If you are contemplating a clinical trial in Alzheimer’s and its related dementias, then the ACTC may be the vehicle to make that trial a reality.

We hope you’ve also heard that the funding opportunity for ACTC trials is open. The first submission date for applications is March 29 and we strongly encourage interested investigators to reach out to the ACTC leadership and NIA well in advance.

In case you haven’t heard, or need a refresher, I’ve listed some important highlights.

Support for five to seven clinical trial awards anticipated

We’re looking for applications to develop and implement Phase I to III clinical trials that would use the ACTC coordination and management infrastructure. We plan to fund promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease and related dementias.

While the number of awards depends on NIH appropriations and the quantity and quality of applications, we expect to fund five to seven clinical trials. We anticipate a total of $10 million for fiscal year 2018 with future amounts depending on annual appropriations.

A cutting-edge consortium

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. For example, ACTC will centralize key functions such as tissue banking, imaging, biostatistics, and data management, as well as implementing a centralized Institutional Review Board. Also, the consortium and trials are funded separately—having dedicated funding means that the trial sites within the consortium can maintain consistent quality standards and staffing which are independent of trial activities.

The ACTC consists of 35 sites plus a coordinating center and 10 units staffed with teams to manage areas such as biomarkers, clinical operations, informatics, magnetic resonance imaging, positron emission tomography, and recruitment. As part of its recruitment unit, the ACTC is establishing a new Minority Outreach and Recruitment Team, which will use innovations in recruitment to support both central and local partnerships with diverse communities.

With scientific input from the NIA, the ACTC is led jointly by Dr. Paul Stephen Aisen, of the University of Southern California, San Diego; Dr. Reisa A. Sperling, of Brigham and Women’s Hospital and Harvard Medical School, Boston; and Dr. Ronald C. Petersen, of the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.

Honoring the past

While the ACTC is new, it builds on previous experience. NIA has been funding large clinical trial consortia since 1991, namely the Alzheimer's Disease Cooperative Study (ADCS), which will continue its ongoing studies. Over the years, the ADCS has conducted numerous trials, as well as several instrument development studies.

We have high expectations that the ACTC will take its place as a next-generation research infrastructure and—with new insights and partnerships—help us quickly find, optimize, and test new treatments for Alzheimer’s disease and related dementias. I invite those of you considering clinical trials in Alzheimer’s to take advantage of this new opportunity.