Alzheimer’s Drug Trial Receives FDA Fast Track Approval

A new drug to treat patients in the early stages of Alzheimer’s Disease was recently granted Fast Track designation by the U.S. Food and Drug Administration, offering hope to increasing numbers of adults diagnosed with this disabling disease.

The FDA’s Fast Track program is designed to expedite the development of new treatments for serious conditions that have an unmet medical need.  To be accepted into the program, a drug must demonstrate advantages over the current therapy such as showing superior effectiveness, avoiding serious side effects or improving the diagnosis of a serious condition where early diagnosis results in a better outcome.

The drug Aducanumab, developed by the biotechnology company Biogen, has shown promise in reducing the hallmark amyloid plaques associated with Alzheimer’s Disease. The Phase 3 Study of Aducanumab in early A.D. is currently recruiting participants. To be eligible for the study, participants must be 50 to 85 years old and meet all the key criteria including having a reliable caregiver.  There are 180 study locations in the United States, Australia, Canada, France, Germany, Italy, Japan, Portugal, Spain, Taiwan and the United Kingdom.

To learn more about the phase 3 studies follow this link.