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Patient Recruitment Completed for Phase 3 Trial of Alzhemed
"Completion of patient recruitment for the Phase III Alzhemed(TM) clinical trial in North America is a major milestone for the Company," said Francesco Bellini, Chairman, President and CEO of Neurochem. "To have recruited this large number of patients in less than one year is an indication of the priority we have placed upon developing this product candidate as well as the interest that Alzhemed(TM) has raised to-date among researchers and physicians. We believe Alzhemed(TM) may be able to provide patients with real hope."
The multi-center, randomized, double-blind, placebo-controlled and parallel designed North American Phase III clinical trial is investigating the safety and efficacy of Alzhemed(TM) for the treatment of AD in mild-to- moderate patients. The patients have been randomized to receive either placebo or one of two different dose levels of Alzhemed(TM) (100mg or 150mg twice daily) for a period of 18 months. All participants must be treated with conventional AD therapies and must be on stable dose for at least four months prior to the screening visit. The two primary efficacy parameters are the change from baseline to month 18 in the ADAS-cog and CDR-SB scores(1). The potential disease modification effect of Alzhemed(TM) is also assessed by brain volume change from baseline as measured by Magnetic Resonance Imaging.
Alzhemed(TM) is an orally administered, small organic molecule that has been specifically designed to modify the course of AD through its anti-amyloid activity. As part of a "disease modifying" novel class of product candidates, Alzhemed(TM) is expected to act at two levels: in preventing and stopping the formation and the deposition of amyloid fibrils in the brain and in binding to soluble A(B) protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.
About Alzheimer's Disease
AD is a leading cause of death in older people. The disease is characterized by the progressive death of nerve cells in the brain, making it difficult for the brain's signals to be transmitted properly. A person with AD experiences problems with memory, judgment, thinking, and eventually with motor functions, all of which make it hard for the person to participate in day-to-day activities.
According to the National Institute on Aging's "Progress Report on Alzheimer's Disease, 2000," AD is the most common cause of dementia among people aged 65 and older. Scientists estimate that up to four and a half million people in the United States currently suffer with the disease and the prevalence (the number of people with the disease at any one time) doubles every five years beyond age 65. It is also estimated that approximately 360,000 new cases (incidence) will occur each year and that this number will increase as the population ages.
In a 2000 report, the Biotechnology Industry Organization estimated that in the United States the total cost of AD is approximately US$100 billion per year.
Source: Neurochem Inc.