Dr. Rovner and his colleagues hope the trial will enable them to determine whether or not NC-758 warrants further testing in a larger trial. They also would like the trial to provide ideas of potentially effective doses and schedules for patients.
In CAA, amyloid, a normal protein, accumulates in blood vessel walls in the brain, weakening them and leading to stroke. Medicines such as NC-758 have been shown in laboratory studies to block the accumulation of amyloid in such vessels.
Alzheimer's disease is characterized by an excessive buildup of amyloid in the brain. Alzheimer's patients who develop amyloid angiopathy have an increased rate of stroke, notes Dr. Rovner, who is also director of the Division of Geriatric Psychiatry and professor of psychiatry and human behavior at Jefferson Medical College. "If the drug shows effects on CAA, it could potentially help patients with Alzheimer's," he says.
"This is the first clinical effort against CAA, a major cause of bleeding strokes in the elderly and a condition that is more common than previously thought, he says." Approximately 30 of every 100,000 Americans 65 or older will develop a brain hemorrhage from CAA.
Even more importantly, "It's the first clinical trial in North America aimed at the protein that accumulates in the brains of Alzheimer's patients," notes Dr. Gandy. The trial is also the first conducted by the newly formed clinical research program at Jefferson's Farber Institute for Neurosciences.
The trial will involve patients at multiple centers who have suffered a hemorrhagic stroke, also known as a cerebral hemorrhage. In the current study, patients will receive NC-758 for 12 weeks.
While most such strokes are not fatal the first time, they are a frequent cause of disability and are often followed by a second stroke. Dr. Rovner notes that the role of CAA as an underlying cause of disease, including hemorrhagic stroke, has become more widely recognized in only the last several years. The trial is being funded by a grant from the National Institutes of Health and is based at the Massachusetts General Hospital.
Jefferson's Farber Institute for Neurosciences is a multidisciplinary neurosciences research center established through a $10 million gift by the Farber Family Foundation, Inc., of Palm Beach Gardens, Fla. It is initially focusing its efforts on basic and clinical research in a number of key areas, including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders. The institute's researchers will continue to build on already-established Jefferson strengths in many of these fields, while establishing new and revitalized research programs in others.
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