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In response to requests from Congress, in March 2000 the National Institutes of Health prepared a detailed “Parkinson’s Disease Research Agenda” that outlines an ambitious approach to developing new treatments. The plan includes trials of drug therapy, cell implantation, deep brain stimulation, and precision surgical ablation. Drug development research includes a combination of small phase 2 and large, randomized, controlled clinical trials. Trials are anticipated of antioxidants, anti-inflammatory agents, glutamate antagonists, inhibitors of the dopamine transporter, and neuroimmunophilins.
The plan also includes expanded use of “seed money” grants such as Exploratory Grants for Innovative Research (R21) and Small Grants (R03) for smaller, innovative, exploratory studies. A mechanism for accelerated review is proposed, with the goal of reducing the time from receipt of proposal to award to no more than six months for standard grants. The plan favors additional stem cell research over fetal tissue transplants. It also points to the need for better animal models of Parkinson’s disease, application of array technologies and high-throughput drug screening, identification of reliable biomarkers as indicators of risk, disease state, and disease severity, and development of brain banks and other tissue repositories for Parkinson’s disease materials. The plan recommends expanding collaboration with private groups such as Parkinson’s advocacy groups and establishment of a Weß-based Parkinson’s disease registry.
A special Web site that will monitor and report progress of the Parkinson’s Disease Research Agenda is available at www.ninds.nih.gov/parkinsonsweb.
The Parkinson’s Disease Research Agenda calls for $70 million of new spending for the first year with increases in later years rising to $287 million in year five. The National Institute for Neurological Disorders and Stroke (NINDS) has already requested proposals for centers to coordinate and manage statistics for a major Parkinson’s disease neuroprotection clinical trial. That study, which is to be designed as a “large, simple” trial, will include about 3,000 participants, last for up to eight years, and will test several potential neuroprotective agents. The NINDS expects this trial to ultimately involve 42 clinical centers as well as the coordinating center and statistical center.
Diane Murphy, PhD, Program Director in the Neurodegeneration Group at NINDS, told Neurology Reviews that the institute also has funded five grants each for researchers studying the protein parkin, synaptic proteins and synapse loss, and mitochondrial degeneration related to oxidative stress, each at about $1.5 million for the first year. NINDS also has funded 12 studies of deep brain stimulation.
The NINDS is currently supporting 11 Parkinson’s Disease Research Centers of Excellence, more commonly known as Udall Centers. Total funding for the centers stands at $73 million. The centers are at Brigham and Women’s Hospital (Boston), Columbia University (New York City), the University of Virginia (Charlottesville), the Mayo Clinic (Jacksonville, Fla), the University of Kentucky (Lexington), Duke University (Durham, NC), the University of California (Los Angeles), Harvard Medical School and McLean Hospital (Belmont, Mass), Emory University (Atlanta), Massachusetts General Hospital (Boston), and Johns Hopkins University School of Medicine (Baltimore).
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