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Memory Pharmaceuticals begins phase-2a clinical trial of MEM 1003 for Alzheimer's disease
By Angela McDaniels
Seattle, Nov. 4 - Memory Pharmaceuticals Corp. said it has begun a phase-2a clinical trial of its MEM 1003 drug in patients with mild to moderate Alzheimer's disease.
The trial will evaluate the safety and efficacy of two dose levels of MEM 1003 as part of an investigational new drug application to the U.S. Food and Drug Administration.
About 80 patients in 50 trial centers throughout the United States will receive 30 mg of MEM 1003, 90 mg of MEM 1003 or a placebo twice a day for 12 weeks.
The primary outcome measure will be the movement of each patient's score on the Cognitive Subscale of the Alzheimer's Disease Assessment Scale. Secondary measures will assess changes in activities of daily living, behavior and global function.
"It is believed that one of the hallmarks of Alzheimer's disease is an impaired regulation of calcium within the central nervous system. As a calcium channel modulator, MEM 1003 has the potential to re-establish normal cellular functioning," said David A. Lowe, chief scientific officer of Memory, in a company press release.
Under the terms of the company's license agreement with Bayer AG, Memory is obligated to make a $1 million milestone payment to Bayer now that the trial has started.
The company said it has also completed a phase-1 clinical trial in the United Kingdom to evaluate the potential cardiovascular impact and side-effect profile produced by single and multiple doses of MEM 1003. The company plans to announce results from the safety and tolerability study during the fourth quarter of 2005.
Memory, a biopharmaceutical company, is based in Montvale, N.J., and develops drugs for the treatment of central nervous system disorders.
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