More than 5 million Americans and their family and friends are living with the irreversible nightmare of Alzheimer’s.
Options to treat the progressive brain disease that destroys memory and cognitive skills are very limited. The FDA has licenced only five drugs over the past 20 years, with the last one gaining approval in 2003.
Early Diagnosis, More Effective Treatment
The way Alzheimer’s is investigated has changed dramatically recently. Previous research has been carried out when symptoms are clearly apparent, but this stage of the disease manifests itself long after changes to the brain have begun to occur. In 2013, the FDA drafted guidelines for research and clinical drug trials that focus on the very earliest stages of the disease, when symptoms may be very subtle or even non-apparent.
According to Eric Bastings, M.D., neurologist and deputy director of FDA’s Division of Neurology Products, a window of opportunity might exist to affect the development of the disease before symptoms become apparent.
New Pathways, New Treatment Options
The National Institute on Aging is currently co-funding a landmark study focusing on participants aged 65 to 85 who currently exhibit normal cognitive and memory function but who may be at risk of developing Alzheimer’s. This three-year study using advanced brain scan technology will assess whether a new anti-amyloid treatment can slow memory loss.
Last year, the FDA approved the use of certain biomarkers to correctly identify patients at risk of developing the memory loss disease, which is the sixth leading cause of death in the US. Although some of the markers are genetic – a gene mutation occurring through generations of the same family – for many, the cause of Alzheimer’s may not be so readily identified.
Bastings hopes that biomarkers will help researchers to more effectively identify candidates for clinical trials and then more clearly demonstrate the effectiveness of new drug therapies.
New Licensing Opportunities
The FDA’s recent decisions offer a raft of opportunities for companies researching new Alzheimer’s treatments. Applying for FDA 510k clearance can be challenging, but looking for reputable companies to help with FDA 510k like www.fdathirdpartyreview.com can simplify the process, bringing valuable therapies to market quickly and efficiently.
For everyone affected by Alzheimer’s, the development of early intervention treatments that safeguard patients’ brain function for as long as possible cannot come soon enough.