New hope in Alzheimer's

Utah's Myriad Genetics reported hopeful findings today that a medication it developed and has been testing for treatment of Alzheimer's disease can slow the disease's early progression.

After taking the drug Flurizan for a year, the decline in patients with mild Alzheimer's slowed significantly, according to the results of the Phase 2 clinical trial of the drug just announced by Myriad.

Researchers used the Alzheimer's Disease Cooperative Study, Clinical Dementia Rating and the Alzheimer's Disease Assessment Scale to measure results in participants who took Flurizan compared to those who took a placebo, or inactive substance.

Patients who received the 800 mg twice-daily dose of Flurizan achieved between 34 percent and 45 percent slowing in decline based on three key measures: daily living activities, overall function and cognitive ability, the release said.

"This study is one of the most successful Phase 2 trials in Alzheimer's disease that I am aware of," said the trial's principal investigator, Dr. Gordon Wilcock, professor in Care of the Elderly, University of Bristol, England. "It is very encouraging for its potential to address a very large and growing worldwide population of patients with mild Alzheimer's disease."

The yearlong study included 207 patients at about 30 centers in the United Kingdom and Canada. Participants were given 800 mg of Flurizan twice daily, 400 mg of Flurizan twice daily or placebo.

Patients with moderate Alzheimer's disease did not appear to benefit on the three primary measures, but they showed a positive trend on the Neuro-Psychiatric Inventory — a measure of psychiatric problems such as agitation paranoia and anxiety that are common in Alzheimer's patients. Myriad is investigating future clinical studies in patients with moderate Alzheimer's disease to explore this finding.

Flurizan was also found to be well tolerated by Alzheimer's patients, according to Myriad, and the company believes Flurizan may be suitable for long-term administration to an elderly population.

Potential drug-related adverse effects were, according to Myriad, mild, non-specific and not statistically different between the Flurizan and placebo groups.

The Phase 2 trial has helped define what form the next phase of clinical trials for the drug will take. The phase 3 trial will enroll about 800 patients in each of two separate "arms" of the study, according to paperwork the company has submitted to the Food and Drug Administration. The FDA must approve plans for each phase of clinical trial.

Wilcock will present the results of the phase 2 study as part of the Alzheimer's Association International Conference on Prevention of Dementia in Washington, D.C., this afternoon.

"We are excited by these data indicating that Flurizan may slow the decline in cognition as well as provide a benefit in behavior and overall function," said Adrian Hobden, president of Myriad Pharmaceuticals Inc. "We look forward to completing enrollment in the Phase 3 trial and demonstrating efficacy and a continued excellent safety profile in a larger trial of Flurizan."

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