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Biotech / Medical : SIBIA Neurosciences (SIBI) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (575)	5/15/2003 4:29:54 PM
From: scaram(o)uche	Respond to of 579

New Study Showed ARICEPT(R) (donepezil HCl tablets) Improved Symptoms at an Early Stage of Alzheimer's Disease Thursday May 15, 3:00 pm ET BALTIMORE, May 15 /PRNewswire/ -- Patients with very mild Alzheimer's disease (AD) showed significant improvement in their memory and thinking when treated with ARICEPT® (donepezil HCl tablets) versus placebo. Early signs of AD include forgetting names, places and facts, as well as experiencing difficulty with everyday activities, such as balancing their checkbook, finding their way around, or remembering where they put things. Study findings were presented for the first time in the U.S. at the 2003 American Geriatrics Society Annual Scientific Meeting. ARICEPT® is indicated for the treatment of mild to moderate Alzheimer's disease. ADVERTISEMENT "Patients and families often wait several years after noticing the first signs of AD before seeking a diagnosis. This is unfortunate because although there is no cure, early diagnosis and treatment may be the best way for patients to slow the progression of symptoms and continue to do everyday tasks and activities, such as managing household finances and carrying on a conversation, for a longer period of time." said Ben Seltzer, MD, Tulane University, Department of Psychiatry and Neurology, New Orleans, LA. "These findings demonstrate that Alzheimer's treatment can improve cognition when started in the earlier or very mild stages of the disease." Patients on treatment demonstrated significant cognitive improvement on the modified Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) (p=0.001) and the Mini-Mental State Examination (MMSE) (p=0.002), compared with those receiving placebo whose cognitive function remained near baseline throughout the study. More than twice as many ARICEPT® than placebo treated patients (42.9 percent vs. 20 percent) experienced at least a three-point improvement from baseline on the modified ADAS-cog, the primary endpoint of the study. Additionally, more than 50 percent of the treatment group demonstrated a 1.5-point increase on the MMSE(1) compared to only 29 percent of untreated patients. Treated patients also showed greater improvement on other secondary tests used to measure efficacy, including the Facial Recognition and Name-Face Association Delayed Recall (p<.05) from the Computerized Memory Battery Test (CMBT).(2) Study Overview In this 24-week, randomized, double-blind, placebo-controlled analysis, 153 patients diagnosed with probable early-stage AD (MMSE = 21-26 inclusive) and a global Clinical Dementia Rating of 0.5 or 1 received either ARICEPT® (n=96) 5 mg once daily for the first 42 days and 10 mg once daily thereafter based on the clinicians judgment, or placebo (n=57). The mean MMSE score at baseline was 24.1 for the ARICEPT® group and 24.3 for the placebo group. Patients were assessed at weeks 6, 12, 18, and 24. Safety and tolerability in these patients were consistent with that observed in patients in pivotal studies using ARICEPT®. Completion rates for the study were 72.9 percent in the ARICEPT® group and 80.7 percent in placebo-treated patients. The most common reason for discontinuation was adverse events (15.6 percent ARICEPT®, 8.8 percent placebo). The most common treatment-emergent adverse events (in at least five percent of ARICEPT® treated patients and in at least twice the rate of placebo) were diarrhea, nausea, asthenia, abnormal dreams, dizziness, accidental injury and insomnia.