Three leading Alzheimer’s researchers are forming a consortium to improve clinical trials in the field — an effort boosted by a $70 million grant from the National Institutes of Health.
Goals of the Alzheimer’s Clinical Trials Consortium include sharing information and resources to make drug development more efficient and finding better ways to recruit patients for trials.
“Combining brainpower to solve this intractable problem is necessary because everyone will be affected, or will know someone affected, by this disease in their lifetime,” Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California’s Keck School of Medicine, said in a press release.
He is spearheading the consortium effort, along with Ronald Petersen of the Mayo Clinic in Rochester, Minnesota, and Reisa Sperling of the Harvard-affiliated Brigham and Women’s Hospital and Massachusetts General Hospital.
The consortium will start by building a network of 35 Alzheimer’s trial sites at universities across the United States. The government’s National Institute on Aging will advise the three founders on the effort.
“We must overhaul our current recruitment strategies for clinical trials, particularly to improve the diversity of our study participants and to reach people who do not yet have symptoms of Alzheimer’s disease for inclusion in future prevention trials,” Sperling, a neurology professor at Harvard Medical School, said in a release.
The consortium is “a terrific opportunity to innovate in [patient] recruitment, cognitive assessments and neuroimaging for the next generation of Alzheimer’s trials,” she added.
A key consortium focus will be overcoming clinical trial recruitment challenges, including the cost of recruiting patients and activating trial sites.
Researchers hope the new effort leads to the recruitment of more patients from varying backgrounds.
Today, African-Americans and Hispanics are underrepresented in Alzheimer’s research, despite the fact that they are more likely to develop the disease than whites.
“Some clinical trials fail simply because time runs out before researchers are able to finish signing collaboration agreements or recruit the requisite number of participants,” Petersen said.
The consortium “will do the hard work of recruiting potential participants,” he said. The trial-ready groups will allow researchers “to spend their time investigating hypotheses and gaining a better understanding of Alzheimer’s disease rather than dealing with tedious logistics.”
The consortium will provide shared support services and work toward improved sharing of information and resources ranging from software to biological samples. The idea is to allow researchers to design better trials as well as to manage and analyze the large amounts of information generated.
Alzheimer’s research is increasingly moving toward early-stage treatment, with an optimum approach of recruiting people who have yet to show symptoms. To advance this strategy, researchers are working on biomarkers and tests that can detect the disease in its early stages.
The National Institutes of Health grant should allow the consortium to manage up to seven trials over five years. Funding for the trials themselves will come from pharmaceutical companies and other organizations.
The consortium founders bring different expertise to the project. Aisen has focused on improving Alzheimer’s trials for 25 years. Part of that has involved creating ways to manage and analyze the massive amounts of information that large trials generate.
Sperling has helped pioneer large trials of potential Alzheimer’s prevention therapies. This has included developing tools to measure cognition and to analyze brain images of those who have yet to display Alzheimer’s symptoms but are likely to develop the disease.
Petersen has also focused on early-stage patients, conducting trails of potential treatments for people with mild cognitive impairment. Many researchers believe a successful treatment at this stage could reverse disease processes.
“This nationwide collaboration will move us closer toward techniques to prevent Alzheimer’s disease,” Aisen said.
“Perhaps one day we’ll be able to do a blood draw to identify individuals in need of preventive measures to stave off dementia and Alzheimer’s disease. We’re not there yet, but we’ve had many promising studies that have provided bread crumbs on how to get there.”
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