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AAN 2024 | New initiatives from NeuroNEXT: clinical trial support for academic and industry partners

Aleksandar Videnovic, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA, introduces the NIH-funded NeuroNEXT network, a robust and accessible infrastructure to facilitate rapid development and implementation of clinical trial protocols in neurological disorders. The Network for Excellence in Neuroscience Clinical Trials brings together a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC) and 20 clinical sites to support the development and execution of Phase II studies and biomarker discovery studies. Dr Videnovic notes that anyone can apply to conduct a study within the network, including academic investigators, advocacy groups, small businesses, and the pharmaceutical industry, where they will receive substantial support for protocol optimization and grant submission to NINDS. Notably, NeuroNEXT is now supporting the development of trials of gene-based and gene-targeted therapies for ultra-rare neurological diseases. This interview took place at the American Academy of Neurology (AAN) Annual Meeting 2024 in Denver, CO.

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Transcript

NeuroNEXT is a clinical trial network. It specifically stands for Network for Excellence in Neuroscience Clinical Trials. This network is supported and funded by the National Institute of Neurological Disorders and Stroke. The network brings together two coordinating centers: one is a clinical coordination center (CCC) at Massachusetts General Hospital, the other is a data coordinating center (DCC) at the University of Iowa...

NeuroNEXT is a clinical trial network. It specifically stands for Network for Excellence in Neuroscience Clinical Trials. This network is supported and funded by the National Institute of Neurological Disorders and Stroke. The network brings together two coordinating centers: one is a clinical coordination center (CCC) at Massachusetts General Hospital, the other is a data coordinating center (DCC) at the University of Iowa. These two coordinating centers are joined by currently 20 clinical sites that participate in these clinical trials.

The overall objective of NeuroNEXT is to support the development and execution of Phase II clinical trials, as well as biomarker discovery studies. One of the very exciting developments in the third iteration of the network, which actually started last year, is the development and support of gene-based therapy trials for ultra-rare neurological disorders. The beauty of this network is that an investigator with a great idea about a clinical trial can pitch their idea and submit it for consideration. If preliminary analysis is deemed favorable, those investigators receive substantial support in further optimization of the protocol development, and support with the grant submission to NINDS for a consideration of the funding. The network has completed ten clinical trials so far. Two clinical trials are currently ongoing, and we have a number of clinical trials in the pipeline. It is a very important initiative in the clinical trials studying a broad range of neurological disorders. Thank you for this opportunity to briefly talk about it. We at NeuroNEXT are very eager to work with not only our academic colleagues across the academic departments, but also with our industry partners, who are also welcome to submit their ideas for Phase II and biomarker discovery trials for consideration for funding with NeuroNEXT.

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