A new clinical trials consortium funded by the National Institutes of Health is expected to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias. The infrastructure of 35 sites across the United States — called the Alzheimer’s Clinical Trial Consortium (ACTC) — 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 the University of Southern California Alzheimer’s Therapeutic Research Institute (ATRI), San Diego, Harvard-affiliated Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, and Mayo Clinic, Rochester, Minnesota. The funds were awarded by the National Institute on Aging (NIA) at NIH, which leads the federal effort in Alzheimer’s research.
Developing effective treatments for Alzheimer’s and related dementias has proven extremely challenging. However, with recent advances in basic science and the identification of potential therapeutic targets, the number and types of possible therapies for testing have grown and are expected to increase significantly. Now, scientists are seeking to intervene as early as possible in disease development, before memory loss and other clinical signs of decline appear. Such early intervention and prevention studies require screening of thousands of volunteers to identify eligible participants, which can be time consuming and can result in delayed recruitment and under-enrollment. Other challenges facing Alzheimer’s clinical trials include: development of more sensitive cognitive assessment and neuroimaging analyses, data management and bioethics considerations.
“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,” said NIA Director Richard J. Hodes, M.D. “The ACTC will provide vital infrastructure, centralized resources and shared expertise to help us more rapidly and optimally test new treatments.”
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
The MADC is looking forward to being involved in such a wonderful program in the future. To read the full article from the NIH, click HERE.