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Executive Summary

SIGMA-TAU ACETYL-L-CARNITINE ALZHEIMER's MULTICENTER TRIALS are set to begin in the U.S. in April at 27 centers specializing in neurological diseases and aging. The 24 physicians and 60-some clinical researchers involved in the Phase III trials, selected by the U.S. arm of the Italian firm Sigma-Tau in conjunction with the National Institute on Aging, hope to enroll 350 Alzheimer's disease patients. In his first visit to the U.S., Sigma Tau SpA President Claudio Cavazza, PhD, addressed the researchers at a meeting on March 10 in New York City. Data, unpublished in the U.S., on 130 patients, purports that acetyl-levocarnitine has a neuroprotective action and appears to slow the progression of Alzheimer's. The mechanism of action is unknown. The drug may work by stabilizing neurons in the brain, thus preventing their degradation, according to Sigma-Tau VP Scientific Affairs Don Ashbrook. The U.S. trials will consist of a one-year, double-blind, placebo-controlled phase and an additional year of open follow-up treatment. Acetyl-L-carnitine will be administered orally from two to four times a day. The company is also developing an injectable form. Standard cognitive and non-cognitive function test batteries will be used for empirical data on a slowdown in the progression of Alzheimer's. Data from ongoing European trials indicate a six-month treatment time before progress is seen, Cavazza told "The Pink Sheet." The lead investigator for the study is Leon Thal, MD, a professor of neurosciences at the University of California-San Diego Medical Center. Other participants and study centers include: Myron Weiner, MD, University of Texas Southwestern Medical Center; Marshall Folstein, MD, Johns Hopkins Hospital; Allen Roses, MD, Duke University Memory Disorders Clinic; Steven Ferris, PhD, and Barry Reisberg, MD, NYU Medical Center Aging & Dementia Research Center; Murray Raskind, MD, and Elaine Peskind, MD, University of Washington-Seattle VA Medical Center; John Blass, MD/PhD, Ronald Black and Karen Nolan, MDs, Cornell University Medical College Burke Rehabilitation Center; Jacob Fox, MD, Rush Alzheimer Disease Center, Chicago; and Richard Mayeux, MD, Columbia-Presbyterian Medical Center. Mayeux was the investigator for one of two pilot studies on the drug. The European trials have involved a total of 1,400 patients to date: 1,000 with various forms of senile dementias and 400 diagnosed as having pure Alzheimer's, Cavazza said. The drug, tradenamed Alcar, recently has been approved for sale in Argentina and Portugal for Alzheimer's. Alcar has been sold in Italy since 1985 for various vascular indications. Glaxo also sells acetyl-L-carnitine in Italy for the same indications under a license from Sigma-Tau. * Sigma-Tau expects the drug to be followed at FDA by the same coordinator (Paul Leber, MD, of the Division of Neuropharmacological Drug Products), who has been monitoring the development of Warner-Lambert's Cognex (tacrine or THA). The company also intends to use a statistician familiar with the area (University of Iowa's Robert Woolson, PhD). Warner-Lambert said March 12 that it is "on schedule" to file the Cognex NDA by mid-year. Warner-Lambert also expects to file an IND for a postsynaptic cholinergic muscarinic agonist in July. Sigma-Tau's U.S. headquarters are in Gaithersburg, MD. The company's sole U.S. product to date is the orphan drug for primary carnitine deficiency in children, Carnitor (L-carnitine), which has been on the market since early 1986. In addition to Carnitor and Alcar, the company also has in development propionyl-L-carnitine for cardiovascular conditions.

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