FDA Proposes New Research Guidelines To Prevent the Early Onset of Alzheimer’s Disease

The US Food and Drug Administration (FDA) has issued a proposal that offers assistance to pharmaceutical companies to research and develop new treatments for Alzheimer’s patients in the early stages of the disease, in an attempt to head off the onset of dementia.

This after researchers at Rush University also announced today that the number of people living with Alzheimer’s disease in the US is expected to triple by the year 2050.

As the baby boom population in the United States ages, the onset of Alzheimer’s disease and a percentage of the population is inevitable.

Alzheimer’s disease is the most common cause of dementia among the elderly, as it slowly destroys memory and the active thought process in the human brain. Alzheimer’s disease is described as an irreversible, progressive brain disease.

The FDA proposal is a valid response to the obvious increase in Alzheimer’s disease in the US as of late.

“The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer’s disease before there is too much irreversible injury to the brain,” said Dr. Russell Katz, M.D., Director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients.”

According to the CDC, 5,000,000+ people in the United States are currently suffering from Alzheimer’s disease in addition to 38 million people worldwide. There is no cure for Alzheimer’s disease and additionally the effects of the disease are irreversible.

The FDA’s proposal explains their current thinking about different ways that researchers can identify and select patients with early onset Alzheimer’s disease, and even those who may be at risk of developing Alzheimer’s disease. The FDA’s draft guidance is titled, “Guidance for Industry, Alzheimer’s disease: Developing Drugs for the Treatment of Early-Stage Disease.”

Up until now, researchers have tried to identify these early-onset Alzheimer’s disease patients by using a protocol that was based on biomarkers for the disease, as well as trying to develop sensitive clinical protocols that detect a slight decrease in mental cognizance.

“This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public,” adds Dr. Katz. “The FDA is committed to vigorously addressing Alzheimer’s disease and will work with industry to help develop new treatments in this early population as expeditiously as possible.”

This newly released FDA proposal on Alzheimer’s disease early-stage research is part of the US Department of Health and Human Services efforts under the national plan to address Alzheimer’s disease initiative, calling for the government and the private sector to intensify efforts at treating and preventing Alzheimer’s disease and related dementias that accompany it, as well as improving care and services to individuals that may contract this debilitating disease.

Jim Donahue

Sources / Links / References

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338659.htm

http://www.nejm.org/

http://www.cdc.gov/aging/aginginfo/alzheimers.htm