Alzheimer's drug

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

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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

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

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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

 

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

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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

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

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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

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

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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

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

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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