Six guidelines to navigate the Aduhelm controversy and (hopefully) help patients with Mild Cognitive Impairment and early-stage Alzheimer’s Disease

By Kaiser Health News | October 13, 2021

The approval of a con­tro­ver­sial new drug for Alzheimer’s dis­ease, Aduhelm, is shin­ing a spot­light on mild cog­ni­tive impair­ment — prob­lems with mem­o­ry, atten­tion, lan­guage or oth­er cog­ni­tive tasks that exceed changes expect­ed with nor­mal aging. After ini­tial­ly indi­cat­ing that Aduhelm could be pre­scribed to any­one with demen­tia, the Food and Drug Admin­is­tra­tion now spec­i­fies that…

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Welcome to the Ultimate Neuroscience Lab: Your Smartphone

By SharpBrains | September 30, 2021

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing this time six sci­en­tif­ic reports and indus­try resources plus a fun illu­sion. #1. Top 10 Men­tal Health Inno­va­tions to Watch: Spe­cial SciAm/ WEF report Hop­ing you enjoy the great series over at Sci­en­tif­ic Amer­i­can and espe­cial­ly #7, titled Wel­come to the Ulti­mate Neu­ro­science Lab: Your Smartphone,…

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Study: Fewer than 1% of geriatric patients with cognitive complaints met Aduhelm research trial criteria. What can we expect about its real-world safety?

By SharpBrains | September 7, 2021

Bio­gen’s Aduhelm label far exceeds clin­i­cal tri­al pop­u­la­tion, study says. That could bring real-world sur­pris­es (Fierce Phar­ma): While the chat­ter sur­round­ing Biogen’s con­tro­ver­sial Alzheimer’s med Aduhelm has large­ly been cen­tered on a piv­otal Medicare reim­burse­ment deci­sion as of late, ana­lysts are point­ing to one new study that sug­gests there may be “room for sur­pris­es” when…

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Veterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence

By SharpBrains | August 16, 2021

VA Health Sys­tem Won’t Cov­er Biogen’s Alzheimer’s Drug (The Wall Street Jour­nal): The Depart­ment of Vet­er­ans Affairs won’t cov­er Bio­gen Inc.’s new Alzheimer’s drug, the lat­est rebuke of the con­tro­ver­sial treat­ment since it was approved ear­li­er this sum­mer. The VA decid­ed not add the drug, called Aduhelm, to its for­mu­la­ry list of avail­able med­i­cines because…

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Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker

By SharpBrains | August 5, 2021

Doc­tors Blast Bio­gen Alzheimer Approval as ‘Reg­u­la­to­ry Fail­ure’ (Bloomberg): Top researchers who advised the U.S. Food and Drug Admin­is­tra­tion on Bio­gen Inc.’s Alzheimer’s drug blast­ed the agency for approv­ing it, call­ing the deci­sion a “reg­u­la­to­ry fail­ure” that is “at odds with the evidence.”

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Update on the aducanumab (Aduhelm) saga, retirement, financial advice, cognitive health, excessive worrying, neurotech, and more

By SharpBrains | June 30, 2021

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, pro­vid­ing this time a sum­ma­ry of the saga around the FDA approval of adu­canum­ab (Aduhelm) as a sup­posed treat­ment for Alzheimer’s Dis­ease, plus a range of time­ly research find­ings and resources for life­long brain health. First, below are some key reads to nav­i­gate “prob­a­bly the worst drug approval…

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