On the other hand, this drug has bad better results:
http://investors.medivation.net//ReleaseDetail.cfm?ReleaseID=322903Medivation Announces Publication in The Lancet of Dimebon Pivotal Trial Results in Alzheimer's Disease
- Dimebon Improved the Clinical Course of Alzheimer's Disease; Patients Experienced Statistically Significant Improvements in Memory and Thinking, Activities of Daily Living, Behavior and Overall Function -
SAN FRANCISCO, July 17, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Medivation, Inc. (Nasdaq: MDVN) today announced publication of the results of its first Alzheimer's disease pivotal clinical trial of the investigational drug Dimebon in the July 19, 2008 issue of The Lancet. In this double-blind, placebo-controlled trial, patients with mild-to-moderate Alzheimer's disease treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function.
After both six months and a full year of treatment, Dimebon-treated patients were significantly better than placebo-treated patients on all key aspects of the disease. The benefit on the primary endpoint, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) at six months, was highly significant (p<0.0001). Patients treated with Dimebon were also significantly improved at six months over baseline on all measures (p=0.005 on ADAS-cog). Dimebon's benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients preserved their starting level of function on each measure of Alzheimer's disease.
"In this study, Dimebon improved the clinical course of Alzheimer's disease, which is important given that the natural course is progressive deterioration over time," said Rachelle Doody, M.D., Ph.D., lead author and the Effie Marie Cain Chair in Alzheimer's Disease Research at the Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine in Houston. "There is a clear need for new treatments that can add value and enduring benefit to the treatment of Alzheimer's disease. The results of this trial suggest that, if the findings are replicated, Dimebon could advance Alzheimer's treatment, offering more hope for patients and their caregivers."
Dimebon was well-tolerated throughout the trial. There was no difference between the Dimebon and placebo groups in the number of patients with adverse events, and the most common side effects seen were dry mouth (18 percent versus 1 percent for placebo) and depressed mood/depression (15 percent versus 5 percent for placebo). Importantly, fewer patients treated with Dimebon had serious adverse events than did patients on placebo at the end of the study (3 percent versus 12 percent; p=0.03).
Additional analyses of the Dimebon pivotal study data presented at recent medical conferences showed that Dimebon's impact extended to caregivers. Behavioral improvements in Dimebon-treated patients resulted in a significant decrease in caregiver distress at six months and at one year compared to the distress of caregivers of placebo-treated patients. Further, after six months, caregivers of Dimebon-treated patients saved approximately one hour per day assisting patients with activities of daily living compared to caregivers of placebo-treated patients.
"The magnitude, consistency and duration of the beneficial effects of Dimebon demonstrated in this trial are striking," said Paul Aisen, M.D., Director, Alzheimer's Disease Cooperative Study (ADCS) and Professor in the Department of Neurosciences, University of California, San Diego (UCSD). "In addition, the drug has been well-tolerated to date and, if the safety profile is replicated in the ongoing international trial, it will be a substantial advance for this patient population prone to drug side effects."
"We are pleased to see our first pivotal trial culminate with publication of its significant findings in such a prestigious journal," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Currently available therapies treat the symptoms of Alzheimer's disease with only modest effect. The Dimebon study is the first study in which a drug has achieved statistically significant benefits of this breadth, size and duration in a one year, well-controlled trial. These data, coupled with our recently announced positive results in Huntington's disease, suggest that Dimebon could be a novel therapy for the treatment of neurodegenerative diseases. We look forward to the completion of our confirmatory pivotal Phase 3 study of Dimebon in Alzheimer's disease."
