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A new era of clinical trials in Alzheimer’s disease and related dementias

Laurie Ryan
Laurie RYAN,
Chief, Dementias of Aging 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.

Alzheimer's Disease Clinical Research Dementia Funding Opportunities

Comments

Submitted by Sandra Lester on January 24, 2018

My gratitude can not be expressed in words. I watched my grandmother, three aunts from my fathers side of the family; my mother and 3 of her sisters and one of her brothers suffer from this demoralizing disease. Families fight over decisions.
I have the beginnings, but if I mention it, we pass it off as normal aging. We need to know how to treat it, and when. So just thank you. Your work may help my children if it is passed down to their generation. I'm 73, I probably won't benefit, but to know it is not being ignored is good.

Submitted by Soraya L. Valles on January 25, 2018

Hy I am working in Alzheimer's disease from University of Valencia, Spain. I am interested in the grants about clinical and basic research. Please tell me if I have the opportunity to collaborate with you.
Yours sincerely
Associate Profesor and chief of laboratory of Neuroscience
Department of Physiology
School of Medicine
University of Valencia

Submitted by Luisa Souza on January 31, 2018

One day we will have the definitive cure for Alzheimer's. I have hope in that.

Submitted by Marcio Feijo on February 27, 2018

Hi! My name is Marcio, and I run a blog in Brazil dedicated to spreading information regarding aging and other related issues (http://www.maisoumais.com). Good to know about Alzheimer’s Clinical Trial Consortium. This is one of the most demanded topics by our readers, and it´s good to be able to give them some up to date information about Alzheimer.