The FDA approved the last Alzheimer’s drug in 2003. Almost twenty years later, researchers have developed a drug to targets one of the prime causes of Alzheimer’s disease (AD), beta-amyloid plaque.
Causes of Alzheimer’s Disease
https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/symptoms-causes/syc-20350447 Most doctors will tell you that the medical profession does not know what causes AD. They do know that plaques build up in the brain and kill neurons that provide memory.
Sometimes a genetic risk factor (https://www.nia.nih.gov/health/alzheimers-disease-genetics-fact-sheet) will almost guarantee AD, such as APOE ɛ2, APOE ɛ3, or APOE ɛ4 which are associated with late-onset AD. The apolipoprotein E (APOE) gene on chromosome 19 increases the risk of AD.
Early-onset AD occurs in people between 30 and 60 years old and affects less than 10% of all AD patients. Genetic risks associated with early-onset AD are amyloid precursor protein (APP) on chromosome 21, presenilin 1 (PSEN1) on chromosome 14, and presenilin 2 (PSEN2) on chromosome 1. When mutations occur in these genes, the risk of AD increases.
The two fundamental causes scientists agree upon are plaques and tangles. The beta-amyloid protein fragments and those pieces of protein cluster together to form a plaque that can disrupt neural communications. Tau proteins can become tangled and can combine with other misshaped tau proteins to develop tangles.
New Drug for AD
https://www.webmd.com/alzheimers/news/20210607/fda-approves-controversial-alzheimers-drug The drug, aducanumab, was approved this week by the FDA. There are still some hurdles that the manufacturer, Biogen, must complete to gain full FDA approval. Last November, FDA’s advisory board recommended against approval. Since then, the results of three additional double-blind, randomized studies of over 3,300 AD patients changed the earlier decision.
Existing drug treatments address the symptoms of AD. Aducanumab focuses on one of the causes – beta-amyloid plaque formation by targeting the anti-amyloid-beta human monoclonal antibody (BIIB037). Clinical trials to date show improvement in both cognition and function.
The new drug does not stop AD but slows it down substantially, improving the quality of life for many AD patients. However, the price tag (https://www.cnbc.com/2021/06/07/biogen-ceo-says-56000-annually-for-alzheimers-drug-is-fair-promises-not-to-hike-price-for-at-least-4-years.html) of $56,000 a year is a hard pill to swallow. It is not known what insurance will cover.
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