The National Institutes of Health (NIH) estimate that as many as 5.3 million people in the US, aged 65 and older, already show symptoms of Alzheimer’s disease. Without effective intervention, those numbers are projected to rise to between 11 and 16 million by 2050.
A new clinical trials consortium funded by the NIH is expected to award up to $70 million over five years to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias. The Alzheimer’s Clinical Trial Consortium (ACTC) will consist of 35 sites in 24 states and Washington, DC, and will address the timeframe, complexity and expense of the recruitment process and site activation for Alzheimer’s trials to find new and effective ways to treat or prevent these devastating disorders.
The ACTC will be led jointly by research teams from USC’s Alzheimer’s Therapeutic Research Institute (ATRI), Harvard-affiliated Brigham and Women’s Hospital and Massachusetts General Hospital and the Mayo Clinic. The funds were awarded by the National Institute on Aging (NIA) at NIH, which leads the federal effort in Alzheimer’s research. NIA will also provide scientific input to the ACTC under the cooperative agreement.
Specific trials would be funded separately, under a process by which investigators can team up with the consortium to undertake research. Funding opportunity announcements for specific ACTC trials are expected to be released in early 2018 and will be open to all qualified investigators. It is anticipated that the ACTC will have the capacity to handle five to seven trials during the five-year award period.
We have reached a critical juncture in Alzheimer’s and related dementias research, with new and exciting opportunities to build upon what we have learned. The ACTC will provide vital infrastructure, centralized resources and shared expertise to help us more rapidly and optimally test new treatments.
– NIA Director Richard J. Hodes, MD
The ACTC experts and infrastructure will support the design and conduct of trials across the full spectrum of Alzheimer’s and related dementias, from prevention initiatives to combination trials for advanced symptomatic stages. Specific objectives of the consortium include:
- Creating infrastructure with expert leadership to streamline implementation of trials
- Developing innovative trial design methods, outcomes and analysis strategies
- Maintaining trial site quality standards during and between trials
- Developing and implementing cutting-edge participant recruitment and retention strategies, especially in diverse populations
- Using a centralized Institutional Review Board
- Developing and running capture systems for data pertinent to the ACTC
- Securing centralized tissue banking for specimens
- Providing centralized imaging, biostatistics, bioinformatics and data management and analysis support
- Facilitating and managing public-private partnerships
When we announced the funding opportunity for a new publicly-supported clinical trials network, we envisioned a next-generation consortium, where shared expertise could enhance the ideas and approaches of individual investigators proposing and conducting trials. I think we will have that now. I am particularly interested in how we can better engage diverse communities into research, so that trials can more effectively include and benefit everyone who is affected by Alzheimer’s.
– Laurie Ryan, PhD, chief of the Dementias of Aging Branch in NIA’s Division of Neuroscience