The National Institutes of Health (NIH) is expected to award up to $70 million over five years to three physician-scientists to launch the Alzheimer’s Clinical Trials Consortium (ACTC) – a network of 35 Alzheimer’s disease trial sites across the country – with the goal of finding new ways to treat or prevent Alzheimer’s.
Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment (CART)at Brigham and Women’s Hospital (BWH), will collaborate with colleagues at Mayo Clinic and the Keck School of Medicine at the University of Southern California (USC) to accelerate clinical trials for Alzheimer’s disease and related dementias.
“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,” says Dr. Sperling, who serves as the principal investigator of the ACTC at both BWH and Massachusetts General Hospital (MGH). “The new ACTC presents a terrific opportunity to innovate in recruitment, cognitive assessments and neuroimaging for the next generation of Alzheimer’s trials,” she says.
The ACTC will be led jointly by research teams across the country including a team from BWH and MGH. Dr. Sperling will work with leaders at other institutions including the University of Southern California, Mayo Clinic, along with scientific input from the National Institute on Aging (NIA) at NIH — the federal leader in Alzheimer’s research.
The consortium’s diverse team and improved infrastructure will alleviate some of the challenges involved in conducting clinical trials, including the expense of recruitment and site activation.
Several other leading researchers at BWH, including Dennis J. Selkoe, MD, co-director of the Center for Neurologic Diseases, Gad A. Marshall, MD, associate medical director of Clinical Trials, Memory Disorders Unit, Dominic Walsh, PhD, and Dorene Rentz, PsyD, will work on ACTC-based efforts at BWH to implement more sensitive biomarkers and cognitive tests in early intervention trials.
The consortium will offer shared support services, enabling researchers to design better clinical trials, manage and analyze large amounts of data, and recruit participants from diverse backgrounds. The group will also share data, software, instruments and biologic samples such as blood, tissue and cerebrospinal fluid with colleagues.
In addition, the ACTC will also help researchers engage in new collaborations to test promising therapies and prevention strategies. Researchers at BWH and their colleagues are leading efforts to find ways to intervene as early as possible, before the first signs and symptoms of Alzheimer’s appear, which is when some treatments are expected to be most effective. But prevention trials – such as the A4 Study led by Dr. Sperling and her collaborators – can require screening thousands of volunteers to identify eligible participants, which can be time- and resource-consuming. The ACTC aims to offer the infrastructure, shared resources and expertise to help surmount these hurdles.