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Alzheimer's drug

CMS: anti-amyloid drug Leqembi (lecanemab) doesn’t meet the “reasonable and necessary” standard required for wider Medicare coverage

February 28, 2023 by SharpBrains Leave a Comment

CMS Sticks to Sharply Lim­it­ed Cov­er­age of New Alzheimer’s Drug, Leqem­bi (Man­aged Health­care Executive):

For now, CMS (Note: Cen­ters for Medicare & Med­ic­aid Ser­vices) is stick­ing to the cov­er­age deci­sion it made for Aduhelm (adu­canum­ab) and apply­ing it Leqem­bi (lecanemab). The deci­sion lim­its Medicare cov­er­age of the two Alzheimer disease’s drugs to Medicare ben­e­fi­cia­ries who have enrolled in clin­i­cal tri­als of the drugs

The deci­sion, which was announced in a press release yes­ter­day, was denounced in strong lan­guage by the Alzheimer’s Asso­ci­a­tion. [Read more…] about CMS: anti-amy­loid drug Leqem­bi (lecanemab) doesn’t meet the “rea­son­able and nec­es­sary” stan­dard required for wider Medicare coverage

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's drug, Alzheimers-Association, amyloid, CMS, dementia, FDA, lecanemab, Leqembi, Medicare, monoclonal antibodies

Could I be wrong? Exploring cognitive bias, curiosity, intellectual humility, and lifelong learning

November 30, 2021 by SharpBrains

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing eight time­ly sci­en­tif­ic and indus­try news plus a few fun teasers to appre­ci­ate our unique human brains.

#1. Could I be wrong? Explor­ing research on cog­ni­tive bias, curios­i­ty, intel­lec­tu­al humil­i­ty, and life­long learning

“None of us thinks that our beliefs and atti­tudes are incor­rect; if we did, we obvi­ous­ly wouldn’t hold those beliefs and atti­tudes. Yet, despite our sense that we are usu­al­ly cor­rect, we must accept that our views may some­times turn out to be wrong. This kind of humil­i­ty isn’t sim­ply virtuous—the research sug­gests that it results in bet­ter deci­sions, rela­tion­ships, and out­comes. So, the next time you feel cer­tain about some­thing, you might stop and ask your­self: Could I be wrong?”

#2. Great inter­view on bilin­gual­ism, sports, edu­ca­tion and neu­ro­plas­tic­i­ty — en español

#3. Should old­er politi­cians, and oth­er lead­ers, under­go cog­ni­tive test­ing? The debate con­tin­ues … here are some good com­ments from the online debate we had last summer:

  • PRO: “Def­i­nite­ly. We rou­tine­ly screen appli­cants for a wide range of jobs. Apply for the police, you will be test­ed. Join the mil­i­tary, you will be eval­u­at­ed. Should we not know if a can­di­date for the high­est posi­tion in the coun­try has a seri­ous emo­tion­al, intel­lec­tu­al or psy­cho­log­i­cal impairment?”
  • CON: “I dis­agree because these tests are very bad at pre­dict­ing how good some­one would be in lead­ing a coun­try. It doesn’t require the abil­i­ty to store a lot of infor­ma­tion in your work­ing mem­o­ry. Being a good leader requires only one essen­tial thing: hav­ing the right priorities.”
  • IT DEPENDS: “Who makes the test? What cog­ni­tive met­rics do we use? The bias­es in that design could lead to sig­nif­i­cant unex­pect­ed or even inten­tion­al­ly skewed results.”

#4. Click Ther­a­peu­tics rais­es fur­ther $52M to build up dig­i­tal ther­a­peu­tics pipeline for depres­sion, insom­nia, smok­ing ces­sa­tion and more

What a year for Click and for dig­i­tal therapeutics!

#5. The Amer­i­can Med­ical Association’s (AMA) to ease access to remote Cog­ni­tive Behav­ioral Ther­a­py Monitoring

The road to heav­en is paved with good decisions…

#6. FDA-approved, Cybin-spon­sored clin­i­cial tri­al to mea­sure ketamine’s impact on the brain via Ker­nel Flow neu­roimag­ing helmet

“The word psy­che­del­ic means ‘mind-man­i­fest­ing,’ but what has been miss­ing is use­ful ‘mind-imaging’—the abil­i­ty to dynam­i­cal­ly trace the neur­al cor­re­lates of human con­scious expe­ri­ence. Con­ven­tion­al neu­roimag­ing just isn’t dynam­ic enough to study the psy­che­del­ic expe­ri­ence in the brain as it hap­pens. This study of ketamine’s psy­che­del­ic effects while wear­ing head­gear equipped with sen­sors to record brain activ­i­ty could open up new fron­tiers of under­stand­ing” — Dr. Alex Belser, Cybin’s Chief Clin­i­cal Officer

#7. Bea­con Biosig­nals rais­es $27M to scale EEG, AI-based neu­ro­bio­mark­er dis­cov­ery platform

“ana­lyz­ing EEGs is labor inten­sive and inter­pre­ta­tion of these tests can vary from one clin­i­cian to another..…Beacon Biosig­nals has assem­bled what it claims is one of the world’s largest clin­i­cal EEG data­bas­es. By apply­ing its pro­pri­etary machine-learn­ing algo­rithms to the data­base, the com­pa­ny says it has iden­ti­fied neurobiomarkers—biological indi­ca­tors that are asso­ci­at­ed with cer­tain groups of patients, drug activ­i­ty, and ther­a­peu­tic efficacy.”

#8. Amy­loid-relat­ed imag­ing abnor­mal­i­ties (ARIA) found in approx­i­mate­ly 40% of patients tak­ing “Alzheimer’s drug” Aduhelm

Not good, yet com­plete­ly pre­dictable, and let’s remem­ber this is for a “treat­ment” cost­ing as much as $100,000/ year with exact­ly ZERO proven clin­i­cal ben­e­fit: “…The researchers found 425 cas­es in the com­bined adu­canum­ab group expe­ri­enced ARIA (41.3%), and ARIA-ede­ma was iden­ti­fied in 362 patients or 35.2%. Of them, 94 (26%) had symp­toms, such as headache, con­fu­sion, dizzi­ness and nau­sea. They found ARIA-micro­he­m­or­rhage and ARIA-super­fi­cial sidero­sis in 197 patients (19.1%) and 151 patients (14.7%), respectively.”

Final­ly, Let’s Thank our unique Human Brains and Minds with a few fam­i­ly-friend­ly riddles

Q: What does, “you must come and vis­it us some­time!” actu­al­ly mean?

 

Wish­ing you and yours a Hap­py & Healthy Hanukkah, Decem­ber and Christmas,

The Sharp­Brains Team

 

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Filed Under: Brain/ Mental Health, Education & Lifelong Learning Tagged With: aducanumab, Aduhelm, Alzheimer's drug, Beacon Biosignals, Click Therapeutics, Cognitive Behavioral Therapy Monitoring, cognitive-bias, cognitive-testing, curiosity, Cybin, depression, digital therapeutics, FDA, insomnia, intellectual humility, Kernel Flow, machine-learning, neuroimaging, neuroplasticity, psychedelic, smoking cessation

Amyloid-related imaging abnormalities (ARIA) found in approximately 40% of patients taking “Alzheimer’s drug” Aduhelm

November 29, 2021 by SharpBrains

Study: Biogen’s Aduhelm Caused Brain Swelling in Over One-Third of Study Par­tic­i­pants (Bio­Space):

Atten­tion is being focused on a side effect of Biogen’s Alzheimer’s drug, Aduhelm (adu­canum­ab). Even before its con­tro­ver­sial approval on June 7, there were cas­es of amy­loid-relat­ed imag­ing abnor­mal­i­ties (ARIA‑E), or cere­bral ede­ma, observed in the tri­als. [Read more…] about Amy­loid-relat­ed imag­ing abnor­mal­i­ties (ARIA) found in approx­i­mate­ly 40% of patients tak­ing “Alzheimer’s drug” Aduhelm

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, adverse side effects, Alzheimer's drug, amyloid-related imaging abnormalities, ARIA, ARIA-E, Biogen, cerebral edema, confusion, dizziness, early Alzheimer's disease, headache, nausea, side effects

On cognitive reframing and biases, stress, mental health tech, Aduhelm backlash, Britney Spears, and more

August 31, 2021 by SharpBrains

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing this time nine sci­en­tif­ic reports and indus­try devel­op­ments to help pro­mote life­long brain and men­tal health.

#1. To low­er stress lev­els and improve prob­lem-solv­ing, prac­tice cog­ni­tive refram­ing instead of venting

“… vent­ing like­ly doesn’t soothe anger as much as aug­ment it. That’s because encour­ag­ing peo­ple to act out their anger makes them relive it in their bod­ies, strength­en­ing the neur­al path­ways for anger and mak­ing it eas­i­er to get angry the next time around. Stud­ies on vent­ing anger (with­out effec­tive feed­back), whether online or ver­bal­ly, have also found it to be gen­er­al­ly unhelp­ful … To get out of that, you can ask the per­son to step back and help you reframe your expe­ri­ence by ask­ing, “How should I think about this dif­fer­ent­ly?” or “What should I do in this situation?”

#2. Head­space and Gin­ger merge to expand and scale up dig­i­tal men­tal health

“The new com­pa­ny would find it push­ing well beyond its cur­rent mind­ful­ness focus to, “pro­vide the full spec­trum of proven, effec­tive vir­tu­al sup­port – from mind­ful­ness and med­i­ta­tion, to text-based behav­ioral health coach­ing, to video-based ther­a­py and psy­chi­a­try – for all types of patient populations.”

Ambi­tious move!

#3. How to read, under­stand and write great med­ical research

12 good tips for stu­dents and every­one else

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

Their inde­pen­dent review con­cludes that “giv­en the lack of evi­dence of a robust and mean­ing­ful clin­i­cal ben­e­fit and the known safe­ty sig­nal, we rec­om­mend against offer­ing this agent to patients with Alzheimer’s demen­tia (mild or oth­er­wise) or mild cog­ni­tive impairment.”

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

A strong call to “learn how this reg­u­la­to­ry fail­ure occurred and to ensure that it doesn’t occur again”

#6. Debunk­ing four myths about deci­sion-mak­ing capac­i­ty to keep Brit­ney Spears and oth­ers safe

Address­ing the ongo­ing con­tro­ver­sy about con­ser­va­tor­ships, a USC Pro­fes­sor of Law, Psy­chol­o­gy, and Psy­chi­a­try shares a great arti­cle to debunk these all-too-com­mon myths

#7. Study exam­ines com­mon cog­ni­tive bias­es (have you tried this brain teas­er?) and ways to mit­i­gate them

If you have not encoun­tered the “Lin­da brain teas­er” before, please give it a try! If you have, you’ll enjoy the new paper titled Tver­sky and Kahneman’s Cog­ni­tive Illu­sions: Who Can Solve Them, and Why?

#8. Inte­grat­ing music, move­ment and stroke reha­bil­i­ta­tion, MedRhythms rais­es $25M to devel­op and com­mer­cial­ize dig­i­tal therapeutic

Fas­ci­nat­ing approach to gait training.

#9. Neu­rotech start-up Paradromics rais­es $20M to address brain-relat­ed dis­or­ders via next-gen brain-com­put­er interfaces

Neu­ralink vs. Paradromics vs. non-inva­sive plat­forms — quite a stim­u­lat­ing space to track

 

Wish­ing you and yours a hap­py and healthy back-to-school and month of September,

The Sharp­Brains Team

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Filed Under: Brain/ Mental Health, Education & Lifelong Learning Tagged With: Alzheimer's drug, Alzheimers-disease, anger, Behavioral Health, beta-amyloid, Biogen, Brain Teasers, brain-teaser, Britney Spears, cognitive, cognitive biases, cognitive reframing, cognitive-bias, Decision-making, digital therapeutic, gait training, Ginger, Headspace, how to read, lower stress levels, MedRhythms, mild-cognitive-impairment, neurotechnologies, Neurotechnology, Paradromics, problem-solving, psychiatry, stroke-rehabilitation, therapy, venting, Veterans Affairs

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

August 16, 2021 by SharpBrains

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 of the drug’s risk of caus­ing seri­ous side effects and a lack of evi­dence that it improves cog­ni­tive func­tion, an agency spokes­woman said. [Read more…] about Vet­er­ans Affairs won’t cov­er Biogen’s new “Alzheimer’s drug” giv­en con­cerns over safe­ty and lack of evidence

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's drug, Alzheimers-disease, betaamyloid plaques, Biogen, cognitive-function, FDA, Formulary, Healthcare-System, improves cognitive function, mild dementia, mild-cognitive-impairment, neurologic disorder, Veterans Affairs

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

August 5, 2021 by SharpBrains

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.” [Read more…] about Alzheimer’s & Demen­tia researchers chal­lenge FDA’s approval of Aduhelm giv­en lack of evi­dence for beta-amy­loid as a marker

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Filed Under: Brain/ Mental Health Tagged With: Aduhelm, Alzheimer's drug, Alzheimers-treatment, beta-amyloid, Biogen, cognitive, FDA approval, surrogate

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