December 15 , 2016 /

Enrolling in an Alzheimer’s disease memory clinical trial

by Frederick W. Schaerf, M.D. | Neuropyschiatric Associates

Since 1906, when Alois Alzheimer described the disease named after him, and identified abnormalities of plaques and tangles in a patient with severe short-term memory loss, no viable treatments to prevent the progression of this devastating memory robbing disorder have been found.  This is despite increased understanding of the biochemical causes, the genetics, the epidemiology and the natural history of the disease.  It is now well established that the plaques described by Alzheimer contain amyloid protein and the tangles contain tau protein.  As well, over 413 clinical trials for Alzheimer’s disease have been carried out between 2002 and 2012, with a failure rate of 99.6%. This changed dramatically in 2015, when Biogen, a pharmaceutical company in Cambridge, Massachusetts, announced that a small Phase 1 trial with 165 participants demonstrated that the infusion of monoclonal antibodies, directed against  brain amyloid (plaques), slowed the cognitive and functional decline in early disease. This caused a flurry of excitement with continued interest and testing of  monoclonal antibodies designed to decrease brain amyloid burden. As well, other efforts are  ongoing, exploring approaches to impact tau, the second abnormal protein found in the tangles described in 1906 by Alois Alzheimer.

For the first time in history, clinical trials have the potential to significantly impact this disease by potentially stabilizing the disease and slow progression.  Incredible clinical trial opportunities are available in Southwest Florida with cutting edge molecules and approaches.  Clinical trials offer state of the art diagnosis, exposure to exciting disease modifying coumpounds all at no cost to the subject.

Despite all of the excitement of early positive results impacting this disease by modifying its progression, obstacles such as a reluctance by those affected by memory loss  to join  clinical trials persists. The belief by some that one is a “guinea pig” are not based in fact.  All new medications are thouroughly tested in

Why Enrolling in an Alzheimer’s Disease or Memory Loss Clinical Trial is in 2016-The Best of Times

years of preclinical and clinical studies, making the risk of an adverse medical event unlikely.  The use of a placebo arm has been criticized although many studies now have an “open label extention,” meaning that everyone recieves the medication after the initial study period.  For example, the Phase III Biogen study has a two year open label extension after the first 18 months of double blind placebo monitoring.  It is clear that this disease starts up to 20 years before a single symptom and the earlier one intervenes, the better the outcome.  If you are over the age of 50, there is not one good reason to not have the health of your brain evaluated.  If you have symptoms of memory loss or have been diagnosed with Mild Cognitive Impairment or Alzheimer’s disease, having an evaluation for participation in a cutting edge clinical trial should be the standard of care in our community.  The Neuropsychiatric Research Center offers free memory screening and encourages participation in one of our many clinical trials designed  to slow  the progression of memory impairments.

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