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Brain Health Registry Offers Promise of New Avenues for Clinical Trial Recruitment

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At my doctor’s office, there is a small sign in the waiting room that says “today’s treatments were yesterday’s research trial.” The sentiment couldn’t be more true. Medical researchers rely on subjects to participate in clinical trials to help them test new medications and treatments for diseases from Alzheimer’s to cancer to complex gastrointestinal and gynecological diseases, and so many more. 

While this can be an unnerving idea for some patients, and some types of trials come with risks since therapies are being tested for the first time in humans, the payoff both personally and for the population as a whole has the potential to be enormous.

But, many researchers still struggle to enroll patients in research studies. About one-third of the cost of running a clinical trial comes from having to recruit patients, and many trials fail or are delayed because of it.

Yvette Sheline, MD, a professor of Psychiatry, Radiology, and Neurology and director of the Center for Neuromodulation in Depression and Stress, is one of the Penn Medicine neuroscientists involved in Alzheimer’s disease research. Sheline’s research aims to identify Alzheimer’s disease prevention strategies. Her work has previously shown that a common anti-depressant can arrest the growth of amyloid beta, the protein implicated in Alzheimer’s, in the brains of mice. Sheline is currently recruiting healthy subjects age 60 plus for an ongoing clinical trial to test whether antidepressants lower the level of amyloid beta protein in human cerebrospinal fluid.

She recently introduced me to the Brain Health Registry, a new online tool designed to create a ready pool of research subjects for studies on neurological diseases, such as Alzheimer’s and Parkinson’s, as well as depression, post-traumatic stress disorder and many other brain ailments. 

The registry invites participants—age 18 and older from anywhere in the world—to complete a medical questionnaire and play brain games to provide a snapshot of their brain function. Participants can also electronically sign an informed consent, allowing researchers to contact them for studies for which they might qualify. All information is gathered in accordance with federal privacy laws under HIPAA. 

The data collected helps scientists study brains as they age, identify markers for diseases, develop better diagnostic tools to stop disease before it develops and increase the ready pool of pre-qualified clinical trial participants.

Its creator, Michael Weiner, MD, founder and principal investigator of the initiative and a professor of Radiology, Biomedical Engineering, Medicine, Psychiatry and Neurology at the University of California at San Francisco (UCSF), said in a press release, “the greatest obstacles to finding a cure for Alzheimer’s and other brain disorders are the cost and time involved in clinical trials. This project aims to cut both and greatly accelerate the search for cures.” The Brain Health Registry is the first neuroscience project to use the Internet on such a scale to advance clinical research.

While the registry is known throughout San Francisco and the Bay Area, Sheline is hoping to expand knowledge to the Philadelphia area. “The data the registry provides is helpful, and we seek to expose a larger population of participants in the Philadelphia area to the existence of the registry,” said Sheline. “We would like to be able to bring trial participants to Penn for tests such as neuropsychological testing and brain imaging studies that complex clinical trials require. The registry has the potential to make this possible.”

Sheline is encouraged by the promise the registry represents, stating, “The Brain Health Registry can give us access to a large and diverse population for potential clinical trial recruitment and would help the many neuroscience researchers at Penn and throughout the region advance our work in trying to find better ways to treat the most debilitating neurological diseases.”  

And it provides a way for healthy people to easily contribute to finding treatments, even cures, for neurological and neurodegenerative diseases, provided they are a match for a clinical trial.

With the incidence of Alzheimer’s in particular expected to rise from 5.1 to 7.1 million by 2025, the need for new prevention strategies, treatments, or a cure is dire.    



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