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San Antonio study examines investigational drug for Alzheimer’s

Posted on Tuesday, June 06, 2006 · Volume: XXXIX · Issue: 23

Contact: Will Sansom
Phone: (210) 567-2579
E-mail: Sansom@uthscsa.edu


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San Antonio residents diagnosed with Alzheimer’s disease may be eligible to participate in a clinical study offered by the Health Science Center. The study will assess whether an investigational drug, Flurizan, can slow Alzheimer’s progression.

Donald Royall, M.D., professor of psychiatry, medicine and clinical pharmacology at the Health Science Center and head of the division of aging and geriatric psychiatry, is the principal investigator for the San Antonio site of the MYRIAD study, a double-blind, randomized, placebo-controlled study to evaluate the optimum dosage and administration of Flurizan.

During a previous phase of studies in patients with mild Alzheimer’s disease, this oral medication appeared to slow cognitive decline in patients who took it for 12 months. Flurizan even appeared to reverse memory loss in a small subset of study participants.

For more information about the study, call (210) 562-5474 (answered 24/7).

Alzheimer’s disease affects 39,000 people in San Antonio and Bexar County, and 79,000 in South Central Texas, according to the Alzheimer’s Association office in San Antonio. Nationwide, 4.5 million Americans and their families are coping with this memory-robbing disease.

Researchers have found abnormal deposits of a toxic protein called amyloid in the brains of Alzheimer’s patients. It is thought that Flurizan slows the formation of these deposits.

Jason Schillerstrom, M.D., assistant professor of psychiatry at the Health Science Center, is one of the MYRIAD study investigators. “The thing that’s exciting about this study is that it represents a new trend in Alzheimer’s research,” Dr. Schillerstrom said. “All previously approved medications act on normal neuron chemistry. This is one of the first drugs to make it to Phase 3 trials that targets the actual disease process itself – formation of amyloid plaques.” A Phase 3 trial is the final step before the U.S. Food and Drug Administration considers a drug for approval.

Amyloid plaques form when gamma secretase, an enzyme that acts like a pair of scissors, cuts the genetic sequence of an amyloid precursor protein at a specific point, making the protein “stickier” and capable of clumping with other amyloid precursor proteins. “Flurizan changes the spot where the enzyme cuts the amyloid precursor protein, making it more water soluble,” Dr. Schillerstrom said. “Then it is more likely not to form the amyloid plaques, which might be responsible for the neuronal death we see in Alzheimer’s patients.”

According to MYRIAD study eligibility criteria, participants must be 55 or older, must have been diagnosed with Alzheimer’s disease, and must be able to tolerate anti-inflammatory medicines. Flurizan is “like a high-strength dose of an anti-flammatory medicine,” Dr. Schillerstrom said.

In previous trial phases, a few patients receiving Flurizan developed stomach ulcers. There is also a very slight risk of heart rhythm effects, so participants and families must decide whether this study is right for them.

The MYRIAD Phase 3 study will be conducted for 18 months at sites throughout the U.S., and will compare outcomes of 800 participants receiving Flurizan with outcomes of 800 on placebo. MYRIAD, maker of Flurizan, is a biopharmaceutical company in Salt Lake City.

 
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