Science & Enterprise subscription

Please share Science & Enterprise

RSS
Facebook
Facebook
Google+
Twitter
Visit Us
LinkedIn
INSTAGRAM

Consortium to Speed, Expand Alzheimer’s Clinical Trials

Paul Aisen

Paul Aisen (University of Southern California)

12 December 2017. A group of medical centers is establishing a network of clinical trial sites and processes for testing new treatments for Alzheimer’s disease. The Alzheimer’s Clinical Trial Consortium is a five-year project with funding from National Institutes of Health expected to reach $70 million, combining University of Southern California, Brigham and Women’s and Massachusetts General Hospitals in Boston, and Mayo Clinic in Rochester, Minnesota.

The consortium aims to expand facilities in the U.S. capable of conducting clinical studies of Alzheimer’s disease, as well as strengthening and standardizing processes in those trials. Alzheimer’s disease is a progressive neurodegenerative condition affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau.

The Alzheimer Clinical Trial Consortium aims to establish 35 expert sites for conducting trials of Alzheimer’s treatments. NIH says researchers are seeking to intervene earlier in the progression of Alzheimer’s disease, which requires the difficult task of recruiting thousands of volunteers for screening before memory loss and other symptoms appear. The initiative also aims to bolster the processes for recruiting and assessing participants, monitoring compliance with rules, and employing modern informatics and analytical tools.

Among the steps planned by the consortium is more ethnically diverse recruitment of participants in clinical trials, with a special team devoted to this effort. As reported by Science & Enterprise in March 2015, former model, actress, and restaurateur Barbara Smith — better known as B. Smith — began a public campaign to recruit more minority participants in clinical trials for brain disorders, including Alzheimer’s disease, who are chronically under-represented. Smith herself was diagnosed with Alzheimer’s disease 4 years earlier.

The consortium is also planning to improve the design and conduct of clinical trials, with a centralized institutional review board to monitor compliance with ethical rules, as well as standardized imaging, biostatistics, bioinformatics, and data management and analysis. In addition, the project plans to centralize tissue banking of specimen samples.

Leading the initiative are Paul Aisen, director of University of Southern California’s Alzheimer’s Therapeutic Research Institute located in San Diego, with Reisa Sperling, professor of neurology at Harvard Medical School, and Ronald Peterson, professor of neurology at Mayo Clinic. Brigham and Women’s Hospital and Mass. General Hospital are affiliated with Harvard Medical School.

“A new therapy for Alzheimer’s disease has not been approved in the past 14 years, and none of the approved therapies actually change the course of the disease,” says Aisen in a USC statement. Aisen adds, “This collaboration will remove some of the barriers that have hamstrung researchers from timely completion of clinical trials in Alzheimer’s disease and other dementias.”

The Alzheimer Clinical Trial Consortium is expected to release funding announcements early in 2018, and have the capacity to support 5 to 7 clinical trials during its 5-year lifetime. While the initiative is authorized to spend up to $70 million over that period, actual spending will depend on the availability of funds each year. In the current (2018) fiscal year, for example, only $1.9 million is appropriated, with the funding period ending in February 2018.

More from Science & Enterprise:

*     *     *

Please share Science & Enterprise ...

Comments are closed.