PHILADELPHIA, PA - Cognitive benefits of galantamine treatment are likely to be sustained for at least two years in patients with Alzheimer's disease, according to a study presented today at the American Academy of Neurology's 53rd Annual Meeting in Philadelphia, PA. While previous studies have demonstrated the benefits of galantamine treatment in terms of efficacy and safety, they have largely been limited to six-month trials.
"Our interest was to study whether galantamine's effects on cognitive function persisted over two years,"says neurologist and study author Rachelle Doody, M.D., PhD.
Doody, of Baylor College of Medicine in Houston, and Paul Kershaw, M.D., examined data from an open label trial that followed a double-blind study of 636 Alzheimer's patients, patients who were randomly selected to receive either galantamine (24 or 32 mg/day) or a placebo for six months, after which they were eligible to receive open-label galantamine for an additional 18 months. The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) was used to measure and compare study group data against the natural decline in cognitive function observed in an historical drug study placebo group. All patient groups had similar entry criteria and baseline characteristics.
Patients who received galantamine throughout the study maintained cognitive benefits above their baseline for the first year, while the placebo comparison group declined. Moreover, ADAS-cog scores for the galantamine group were significantly better than the estimated scores of the placebo group at two years, and the cognitive benefits of galantamine increased over time, relative to the predicted rates of decline in untreated patients.
"We do not know yet whether the sustained benefits of galantamine are related to its ability to modulate nicotinic receptors in addition to its activity as a cholinesterase inhibitor," says Doody, but the issue is under study.
The study was supported by Janssen Research Foundation, the drug-discovery arm of Janssen Pharmaceutica, which developed galantamine under an agreement with Shire Pharmaceuticals Group.
The American Academy of Neurology, an association of more than 17,500 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.
For more information about the American Academy of Neurology, visit its website at www.aan.com.
For more information contact:
Kathy Stone, 651-695-2763
May 5-11, 215-418-2420
Editor's Note: Study author Rachelle S. Doody, MD, PhD, will present the research at the American Academy of Neurology's 53rd Annual Meeting in Philadelphia, PA, during a platform presentation on Thursday, May 10, 2001, at 3:45 pm in the Lecture Hall at the Pennsylvania Convention Center.