Aduhelm

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 physical activity, neuroplasticity, depression, screen time, neuromodulation and more

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing this time eight sci­en­tif­ic reports and indus­try resources plus a few fun brain teasers.

#1. Study finds ulti­mate hack to pro­tect teen brains from harm­ful screen time: Exer­cise (and good role-mod­el­ing):

“Girls who spent less than an hour on screens and boys who spent less than 90 min­utes on screens were not neg­a­tive­ly impact­ed by it. But at high­er amounts of screen time, their life sat­is­fac­tion dropped significantly—they were less hap­py with their lives, and it got worse the more time they spent … (the) study also found that teens who got more reg­u­lar exer­cise had greater life sat­is­fac­tion and few­er phys­i­cal com­plaints for both gen­ders. Not only that, the effects were large­ly unre­lat­ed to how much time a teen spent on screens, so that if teens exer­cised more, it could poten­tial­ly undo the dam­age to their well-being that went along with even six or eight hours of screen time.”

#2. Stud­ies find grow­ing evi­dence link­ing weight, phys­i­cal activ­i­ty, neu­ro­plas­tic­i­ty and depres­sion:

‘Obe­si­ty and depres­sion are both major glob­al health chal­lenges, and our study pro­vides the most robust evi­dence to date that high­er BMI caus­es depres­sion,’ said lead author Jess O’Loughlin. ‘Under­stand­ing whether phys­i­cal or social fac­tors are respon­si­ble for this rela­tion­ship can help inform effec­tive strate­gies to improve men­tal health and wellbeing.’

#3. Dr. Judith Beck on the future of cog­ni­tive ther­a­py and psy­chother­a­py:

Let’s hope! — “I think Cog­ni­tive Behav­ioral Ther­a­py (CBT) will con­tin­ue to be adapt­ed for more prob­lems, diag­noses, and con­di­tions. We will train many kinds of care­givers, teach­ers, front-line work­ers, police, and even politicians.”

#4. Ratio­nal­i­ty doesn’t equal effi­cien­cy: Cell­phone data shows how we nav­i­gate cities:

“We dis­cov­ered that the most pre­dic­tive mod­el – rep­re­sent­ing the most com­mon mode of city nav­i­ga­tion – was not the quick­est path, but instead one that tried to min­i­mize the angle between the direc­tion a per­son is mov­ing and the line from the per­son to their des­ti­na­tion … Evo­lu­tion is a sto­ry of trade-offs, not opti­miza­tions, and the cog­ni­tive load of cal­cu­lat­ing a per­fect path rather than rely­ing on the sim­pler point­ing method might not be worth a few saved min­utes. After all, ear­ly humans had to pre­serve brain pow­er for dodg­ing stam­ped­ing ele­phants, just like peo­ple today might need to focus on avoid­ing aggres­sive SUVs.”

#5. Trend: Har­ness­ing dig­i­tal tech to improve men­tal health and well­ness:

“Designed with the help of Dutch aca­d­e­m­ic Isabela Granic … the game is cen­tred around an avatar who stays in bed for the day and aims to relax play­ers by using sooth­ing music, mut­ed colours and self-care prac­tices. Think med­i­ta­tive tasks such as word games and guid­ed breath­ing exer­cis­es. There’s no way to win, com­pete or binge – in fact, it delib­er­ate­ly starts to feel bor­ing after a few min­utes of play, which dis­in­cen­tivizes mind­less scrolling. #Self­Care was an instant hit, gar­ner­ing half a mil­lion down­loads in its first six weeks with­out any advertising…”

#6. Study: Per­son­al­ized, closed-loop neu­ro­mod­u­la­tion can (one day) become a “pace­mak­er for the brain”:

“What made this proof-of-prin­ci­ple tri­al suc­cess­ful was the dis­cov­ery of a neur­al bio­mark­er – a spe­cif­ic pat­tern of brain activ­i­ty that indi­cates the onset of symp­toms – and the team’s abil­i­ty to cus­tomize a new DBS device to respond only when it rec­og­nizes that pat­tern. The device then stim­u­lates a dif­fer­ent area of the brain cir­cuit, cre­at­ing on-demand, imme­di­ate ther­a­py that is unique to both the patient’s brain and the neur­al cir­cuit caus­ing her illness.”

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

“After ini­tial­ly indi­cat­ing that Aduhelm could be pre­scribed to any­one with demen­tia, the Food and Drug Admin­is­tra­tion now spec­i­fies that the pre­scrip­tion drug be giv­en to indi­vid­u­als with mild cog­ni­tive impair­ment or ear­ly-stage Alzheimer’s, the groups in which the med­ica­tion was studied.
Yet this nar­row­er rec­om­men­da­tion rais­es ques­tions. What does a diag­no­sis of mild cog­ni­tive impair­ment mean? Is Aduhelm appro­pri­ate for all peo­ple with mild cog­ni­tive impair­ment, or only some? And who should decide which patients qual­i­fy for treat­ment: demen­tia spe­cial­ists or pri­ma­ry care physicians?”

#8. The Fed­er­al Trade Com­mis­sion (FTC) hard­ens data secu­ri­ty rules for health apps and devices:

“With data breach­es on the rise, the FTC is look­ing to make health apps more account­able for telling patients when their data has been exposed.”

 

Wish­ing you and yours a sweet Hal­loween and a healthy month of November,

The Sharp­Brains Team

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

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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 the pre­scrip­tion drug be giv­en to indi­vid­u­als with mild cog­ni­tive impair­ment or ear­ly-stage Alzheimer’s, the groups in which the med­ica­tion was studied.

Yet this nar­row­er rec­om­men­da­tion rais­es ques­tions. What does a diag­no­sis of mild cog­ni­tive impair­ment mean? Is Aduhelm appro­pri­ate for all peo­ple with mild cog­ni­tive impair­ment, or only some? And who should decide which patients qual­i­fy for treat­ment: demen­tia spe­cial­ists or pri­ma­ry care physi­cians? [Read more…] about Six guide­lines to nav­i­gate the Aduhelm con­tro­ver­sy and (hope­ful­ly) help patients with Mild Cog­ni­tive Impair­ment and ear­ly-stage Alzheimer’s Disease

Welcome to the Ultimate Neuroscience Lab: Your Smartphone

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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, by Emory neu­roethi­cist Karen Rom­melfanger and our very own Álvaro Fer­nán­dez Ibáñez.

#2. Five thoughts to think about when think­ing about the speed of thought

The time it takes for all thoughts to occur is ulti­mate­ly shaped by the char­ac­ter­is­tics of the neu­rons and the net­works involved. Many things influ­ence the speed at which infor­ma­tion flows through the sys­tem, but three key fac­tors are: dis­tance, myeli­na­tion, complexity,

#3. Study: Self-guid­ed sleep app Sleepio, com­bined with stan­dard care for depres­sion and anx­i­ety, deliv­ers bet­ter out­comes than stan­dard care alone

“This eval­u­a­tion revealed sig­nif­i­cant val­ue in intro­duc­ing an evi­dence-based dig­i­tal sleep inter­ven­tion at scale with­in a clin­i­cal men­tal health ser­vice,” researchers from Big Health and Oxford Health NHS Foun­da­tion Trust conclude.

#4. On uncer­tain­ty, stress, emo­tion reg­u­la­tion, and carpe diem

“These find­ings from three stud­ies with diverse sam­ples and method­olo­gies under­score an upside to the specter of uncer­tain­ty: it can cause peo­ple to savor the pos­i­tives of the present.”

#5. Study finds ADHD is asso­ci­at­ed with dementia

“Specif­i­cal­ly, par­ents of an ADHD child have a 34% high­er risk of demen­tia and 55% high­er risk of Alzheimer’s, the results showed. Grand­par­ents have about an 11% increased risk of either condition.”

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

As the researchers point out, “It is thus clear how the result­ing gap between the research and “real world” fields is mas­sive.” We do have the impres­sion that the Aduhelm FDA saga is far from over.

#7. Quick brain teas­er: What do you see? And, can you unsee it?

Have a minute? Give it a try 🙂

 

Wish­ing you and yours a hap­py and healthy month of October,

The Sharp­Brains Team

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

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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 it comes to the treatment’s safe­ty. [Read more…] about Study: Few­er than 1% of geri­atric patients with cog­ni­tive com­plaints met Aduhelm research tri­al cri­te­ria. What can we expect about its real-world safety?