Many people in the United States suffer from Alzheimer’s disease.
Alzheimer’s disease is the sixth leading cause of death in the US and has become the primary cause of dementia in people age 60 and over. Currently, over 5 million people in the United States have this condition, which gradually destroys memory and other cognitive abilities. The effects of this condition have proven to be irreversible as it gradually takes away a person’s ability to do daily cognitive functions.
Scientists have aggressively attempted to discover intervention strategies and treatment techniques for Alzheimer’s, but the results have been few. Over the past 20 years, the FDA has approved five medications for Alzheimer’s, and one of these was just discovered as recently as 2003. Drugs only provide so much benefit, so there must be more done to treat this disease.
Studies have shown that it takes several years for the brain abnormalities develop that characterize Alzheimer’s. In the past, the focus of study has been done after the symptoms were undeniable, but that is many years after the brain changes have already taken place. Researchers propose that the best treatment for the disease must occur during the early stages of the disease: either at the earliest onset of obvious Alzheimer’s symptoms or earlier than that.
That’s why medications for the disease have shifted the focus on treating the condition before the more serious stages of dementia have occurred. In 2013, the FDA approved of a draft guidance to assist companies that desire to do clinical studies targeting intervention strategies aimed at treating the condition before the onset of dementia, a stage in the disease that may prove to be more treatable.
Dr. Eric Bastings, Deputy Director of the Division of Neurology Products for the FDA claims that the best window of opportunity for aggressively treating the disease must occur before people start experiencing the more obvious symptoms.
The 2013 FDA draft guidance looks promising as a tool to assist researchers in creating clinical trials for early stage Alzheimer’s therapies. The guidance is designed to promote dialog between new drug sponsors, the FDA, the academic/research community and the public.
Neurologists in the Division of Neurology Products for the FDA agree that the earlier the diagnosis in patients during the earlier stages of brain changes, the better the success of the clinical studies. Therefore, the FDA’s intention is to discover efficient and safe early intervention methods to prevent extensive brain damage.
The FDA’s draft guidance hopes to influence clinical trials at the earliest stages of Alzheimer’s as possible—even if no obvious symptoms are present.