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A clinical trial will begin soon to test a new type of drug that attacks amyloid, the protein substance that accumulates in the brains of Alzheimer's disease patients.
The buildup of amyloid and the formation of tangles and plaques in the brain are thought to be major causes of Alzheimer's disease.
Neuroscientists at the Farber Institute for Neurosciences at Thomas Jefferson University in Philadelphia will examine the effectiveness of the drug Alzhemed in halting the development of amyloid plaques and the progression of mild to moderate Alzheimer’s disease.
Currently available medications such as Aricept, Reminyl, Exelon and Namenda treat only disease symptoms.
Researcher Dr. Barry Rovner said it is hoped that Alzhemed will stabilize the course of the disease and modify its progression. "It's aimed at what is thought to be the central problem in the disease -- the buildup of protein in the brain that disrupts its message system."
Scheduled to last 18 months, the trial will enroll about 950 Alzheimer's patients with a mild-to-moderate form of the disease. About 50 centers in the United States and 20 in Canada will participate.
Trial participants will receive one of three treatment arms. One group of patients will receive 100 mg of Alzhemed twice a day. Another group will receive 150 mg of Alzhemed twice a day, while a third group will get a placebo.
To be eligible, patients need to be on one of the existing Alzheimer's medications for four months. Potential participants are screened for eligibility using a cognitive skills test.
"What is unique about this trial is its length -- 70 weeks," said Rovner. "Most drug trials don't last that long. Because we are investigating Alzhemeds' impact on disease course, the extended followup is necessary to examine more precisely whether a disease-modifying effect occurs."
Rovner said currently available Alzheimer’s drugs called cholinesterase inhibitors don't work on the amyloid protein. Instead, they block enzymes that degrade acetylcholine, a neurotransmitter important for memory in the central nervous system.
To date, no serious side effects related to Alzhemed have been reported, although some people have had mild, transient nausea or vomiting, according to the researchers.
Source:
Medical Week staff, week of November 6, 2004

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