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| |  Exelon (Rivastigmine Tartrate) Delays Progression Of Mild To Moderately Severe Alzheimer's Disease INDIANAPOLIS, IN -- November 13, 2000 -- Results of a 52-week multi-center study published in the November issue of European Neurology, which show that rivastigmine tartrate reduces the cognitive decline of people with mild to moderate Alzheimer's disease, were reported by Martin R. Farlow, MD, Professor and Vice Chairman for Research, Department of Neurology, Indiana University School of Medicine. Rivastigmine is a cholinesterase inhibitor marketed as Exelon® by the Novartis Pharmaceuticals Corporation for the treatment of mild to moderate dementia of the Alzheimer's type. Dr. Farlow found that patients treated daily with 6 to 12 mg of rivastigmine had significantly better cognitive function over the course of 52 weeks than patients initially treated with placebo or lower doses of the drug. The study was conducted in two phases. The first phase was a double- blind, placebo-controlled trial of 26 weeks duration in which patients were randomized to receive doses of 1 to 4 or 6 to 12 mg/day of rivastigmine or placebo. In the second open-label phase, all patients, even those originally on placebo, were started on rivastigmine 2 mg/day and were progressively increased to their maximum tolerated dosage, up to 12 mg/day. "The original placebo patients who were switched to rivastigmine showed significant cognitive improvement, but did not quite catch up to the patients treated with 6 to 12 mg daily from the start," said Dr. Farlow. The effects of the treatment were assessed by evaluating patients with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). Patients treated with placebo during the 26-week trial had a mean decline of 3.8 ADAS-Cog points, while those on high-dose rivastigmine improved by 0.8 points. There were 545 patients who completed the initial phase of the trial; 532 then agreed to enter the six-month, open-label extension trial. By the end of this 52-week trial, patients who originally received placebo during the first 26 weeks had less improvement on the ADAS-Cog test than patients who received rivastigmine during the entire 52-week period. Patients who received the higher dose of rivastigmine from the start of the study had higher ADAS-Cog scores at the end than either the original placebo or low-dose rivastigmine groups. "This study suggests that early treatment with 6 to 12 mg daily of rivastigmine may provide benefits that are lost if treatment is delayed," said Dr. Farlow. "The failure of delayed treatment to provide the same benefits of earlier therapy is evidence that suggests rivastigmine may affect the biological progression of the disease." The clinical trial was supported by Novartis and conducted at 22 sites across the United States. Related Links: Rivastigmine (ExelonŽ) and Novartis Pharmaceuticals Corporation.
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