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Duke receives NINDS grant for early neurotherapeutic clinical trials

Friday, July 29, 2016

The Department of Neurology is expected to play a major role in a Duke-wide grant of up to $19 million to lead early-stage clinical trials. The clinical trials will investigate new drugs to treat neurological conditions such as Alzheimer’s disease and neuropathy.

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), awarded the 10-year contract to Duke to design, manage, and conduct Phase I clinical trials. The trials will be conducted at the Duke Clinical Research Unit (DCRU), the early-phase clinical trial unit of the Duke Clinical Research Institute (DCRI) (photo). Faculty and housestaff within the Neurology Department will likely play a critical role in the trials themselves.

Andrew Krystal, MD, director of the Neurosciences Medicine Research Program at the Duke Clinical Research Institute, will serve as the principal investigator for the trials. The Department’s Daniel Laskowitz, MD, MHS, will act as chair of the protocol development core, while Jeffrey Guptill, MD, MA, will chair the protocol implementation core.

“This award reinforces Duke’s position as a leader in early-phase trials,” Krystal said. “It’s an opportunity for faculty across multiple disciplines to contribute, and for Duke to be engaged at the ground level in the development of new treatments for neurological disorders.”

Support for the contract will be provided as part of the NIH Blueprint for Neuroscience Research Neurotherapeutics Network. The goal of the network is to speed the transition of promising new therapies from the lab to the clinic by supporting early stages of research and then working with industry to get treatments to patients.

The full-service Phase I Clinical Trial Unit for Neurotherapeutics will evaluate new compounds or therapies that intervene on a molecular level, including small molecules, peptides, proteins and oligonucleotides. Most of the trials will assess the rate of drug absorption into the body as well as the time it takes for drug elimination. The studies will also evaluate drug safety in people and help identify maximum tolerated dosages. In some cases, patients with neurological conditions may be included, but most early trials will test drugs in healthy people.

This story is based on a press release written by Samiha Khanna, which originally appeared on Duke Health's website. Read it here.