Drug appears to stabilize Alzheimer's patients

Benefits of an experimental medication for people with mild Alzheimer's disease seem to continue to at least 15 months' use, according to Myriad Genetics' follow-on study to a Phase 2 clinical trial. And while Myriad plans to study that benefit for another nine months in the original research subjects, it's also signing up 1,600 patients for a Phase 3 study of the drug, Flurizan.

Flurizan is the first "candidate" in a new class of drugs that are being called selective amyloid beta-lowering agents (SALAs). In cellular assays and animal models it lowered levels of Abeta42, the main ingredient of senile plaques that accumulate in the brains of patients with Alzheimer's disease. Abeta42 seems to be an important factor in the disease, according to Myriad spokesman and vice president William A. Hockett. Most genetic mutations that cause early-onset Alzheimer's disease seem to do it by ramping up production of Abeta42.

"People leveled off. It was striking that during these three months, there was a stabilization and no further decline," at 800 mg dosage, he said. Those receiving 400 mg did not experience the same benefits, and Myriad has no intention of continuing to study the drug at that lower dose, which it deemed inadequate, he said.

The Phase 2 clinical study followed patients for 12 months and found that Flurizan at doses of 800 mg twice a day stabilized the mental decline for those with mild Alzheimer's, while those on placebo continued to decline. The new data suggest those benefits continue, at least to the point in time now studied, 15 months. When the follow-on study is concluded, Myriad will have data on what happens to patients who are on the medication for a total of two years.

On Thursday the interim data, covering the 12th to 15th month on the drug, were presented to the Congress of the International Psychogeriatric Association in Stockholm, Sweden, by the study's principal investigator, Dr. Gordon Wilcock of the University of Bristol, UK.

The mental decline was measured by using the Alzheimer's Disease Assessment Scale, cognitive subscale test. When Myriad completed its yearlong Phase 2 trial of Flurizan, 81 percent of study participants in Canada accepted the offer to take the drug for another year. Those who had received placebo in the original study were randomized to either 400 mg or 800 mg doses of the active drug twice a day. Those who received the active drug in the initial trial continued on the same dose.