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aducanumab

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

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

September 7, 2021 by SharpBrains

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?

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's med, American Geriatrics Society, Biogen, cognitive, cognitive complaints, FDA, Medicare reimbursement, undetected side effects

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

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

June 30, 2021 by SharpBrains

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 deci­sion in recent U.S. his­to­ry” — Dr. Aaron Kessel­heim, the Pro­fes­sor of Med­i­cine at Har­vard Med­ical School who resigned rom the FDA Advi­so­ry Com­mit­tee in protest.

#1. Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Bio­gen:

“The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm by Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with known harms.”

#2. First, do no harm? Six rea­sons to approach anti-amy­loid drug Aduhelm cau­tious­ly, if at all:

“The FDA’s approval of Aduhelm rais­es more ques­tions and cre­ates more prob­lems than a new drug approval should. It’s time for gov­ern­men­tal, pro­fes­sion­al, and advo­ca­cy enti­ties to step in where Bio­gen and the FDA have failed and explain to patients, care­givers, and clin­i­cians how this drug is not the “new day” in the fight against Alzheimer’s dis­ease and needs to be approached cau­tious­ly, if at all.” — Dr. Sam Gandy, Pro­fes­sor of Neu­rol­o­gy and Psy­chi­a­try at the Icahn School of Med­i­cine at Mount Sinai, where he holds the Mount Sinai Chair in Alzheimer’s Research

#3. Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can):

“In short, while the amy­loid hypoth­e­sis has fal­tered, the approval of adu­canum­ab, which is based pri­mar­i­ly on this the­o­ry, sug­gests that the the­o­ry may once again dom­i­nate research, and could reduce the chances of find­ing more promis­ing treat­ments. For exam­ple, tau pro­tein, which also accu­mu­lates in the brains of Alzheimer’s patients — long before the amy­loid pro­tein does — has been shown to be close­ly asso­ci­at­ed with the cog­ni­tive impair­ment result­ing from the dis­ease … we must not inter­rupt research on bio­mark­ers and new ther­a­peu­tic approaches.”

#4. US Sen­a­tor Joe Manchin calls for a new FDA Com­mis­sion­er to replace cur­rent (act­ing) one who “has repeat­ed­ly ignored pub­lic health con­cerns and shown a dere­lic­tion of duty” over opi­oids and adu­canum­ab:

“I write today con­cern­ing the lack of per­ma­nent lead­er­ship at the Food and Drug Admin­is­tra­tion (FDA), and the con­tin­ued tenure of Dr. Janet Wood­cock as inter­im com­mis­sion­er. Just last week, the FDA grant­ed approval for Aduhelm (adu­canum­ab), a treat­ment for Alzheimer’s, despite its advi­so­ry pan­el vot­ing near­ly unan­i­mous­ly against its approval, with no pan­el mem­ber vot­ing in favor of approval”

(Let’s hope some­thing use­ful emerges from this very unhealthy FDA deci­sion. Quite dis­turb­ing, though, to notice the links between the opi­oid epi­dem­ic and the recent Aduhelm approval.)

#5. Health payers–including Medicare and Point32Health–to ques­tion Aduhelm pric­ing and its “rea­son­able and nec­es­sary” use:

“Under the broad label that FDA approved, the drug is avail­able to all Alzheimer’s patients, and the agency did not place lim­its on treat­ment dura­tion sug­gest­ing that patients could remain on the drug indef­i­nite­ly. We are trou­bled by reports that those fac­tors could lead the drug to com­mand “some­where between” the $37 bil­lion we cur­rent­ly spend on Medicare Part B and the $90 bil­lion we cur­rent­ly spend on Medicare Part D. This lev­el of poten­tial new spend­ing, par­tic­u­lar­ly for just one prod­uct with lim­it­ed evi­dence of clin­i­cal effi­ca­cy thus far, tests the program’s resiliency.”

The stakes could­n’t be higher.

Now let’s review oth­er impor­tant devel­op­ments in June.

#6. Debate: What is the role of finan­cial advi­sors and plat­forms in detect­ing and address­ing cog­ni­tive decline among old­er clients?:

” … big do-it-your­self invest­ing and trad­ing venues like Van­guard Group, Fideli­ty Invest­ments and Charles Schwab Corp. are strength­en­ing some of the ways they detect pos­si­ble signs of decline. Among oth­er things, all three firms check for clients’ dif­fi­cul­ty nav­i­gat­ing secu­ri­ty pro­to­cols or need for fre­quent pass­word resets. In such cas­es, a des­ig­nat­ed fam­i­ly mem­ber might be informed.

Van­guard also checks client-call record­ings for keywords—such as “con­fused” and “dementia”—that might sig­nal trouble.”

#7. Study in Chi­na finds that retire­ment may accel­er­ate cog­ni­tive decline, even for those with sta­ble income:

“While retire­ment schemes like the 401(k) and sim­i­lar pro­grams in oth­er coun­tries are typ­i­cal­ly intro­duced to ensure the wel­fare of aging adults, our research sug­gests they need to be designed care­ful­ly to avoid unin­tend­ed and sig­nif­i­cant adverse con­se­quences. When peo­ple con­sid­er retire­ment, they should weigh the ben­e­fits with the sig­nif­i­cant down­sides of a sud­den lack of men­tal activ­i­ty. A good way to ame­lio­rate these effects is to stay engaged in social activ­i­ties and con­tin­ue to use your brains in the same way you did when you were working.

In short, we show that if you rest, you rust.”

#8. The explo­sion of men­tal health apps rais­es sub­stan­tial opportunities–and tough ques­tions:

“Dig­i­tal men­tal health can be viewed as a way to extend the men­tal resources that we have,” said David Mohr, who directs the Cen­ter for Behav­ioral Inter­ven­tion Tech­nolo­gies at the North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine. A step-care mod­el, for exam­ple, would allow patients with milder symp­toms to be treat­ed via tech­nol­o­gy while reserv­ing in-per­son care for patients who need some­thing more.

#9. Pre­scrip­tion soft­ware firm Pear Ther­a­peu­tics to go pub­lic via $1.6 bil­lion SPAC deal, har­ness­ing 3 FDA-autho­rized prod­ucts and 14 can­di­dates:

“Pear is one of nine com­pa­nies invit­ed to par­tic­i­pate in the U.S. Food and Drug Administration’s (FDA) Pre­cer­ti­fi­ca­tion Pilot Pro­gram. Pear has devel­oped and com­mer­cial­ized the first three FDA-autho­rized PDTs, has 14 prod­uct can­di­dates, and is scal­ing its plat­form for third-par­ty prod­uct dis­tri­b­u­tion oppor­tu­ni­ties. The Company’s three FDA-autho­rized prod­ucts, reSET®, reSET‑O® and Som­ryst®, address large mar­ket oppor­tu­ni­ties with more than 20 mil­lion patients suf­fer­ing from sub­stance and opi­oid use dis­or­ders and more than 30 mil­lion from chron­ic insom­nia, in the U.S. alone, respectively.”

#10. Don’t wor­ry, be hap­py: How exces­sive wor­ry­ing may influ­ence the rate of neu­rode­gen­er­a­tion:

“(Research find­ings) sug­gest that cog­ni­tive func­tion may need to be mon­i­tored close­ly in indi­vid­u­als with affec­tive dis­or­ders, as these indi­vid­u­als may be at par­tic­u­lar risk of greater cog­ni­tive decline.”

#11. Smarter cars are com­ing soon … : Eye-track­ing pio­neer Smart Eye acquires MIT spin-off Affec­ti­va to aug­ment dri­ver mon­i­tor­ing sys­tems and more

#12. And, much more: DARPA-fund­ed non­sur­gi­cal neu­rotech­nolo­gies push the fron­tier of brain-machine interfaces

Final­ly, a quick cog­ni­tive exer­cise. Giv­en the uni­ver­sal beau­ty of math, you don’t need to speak Span­ish to try this quick teas­er: Brain teasers en español: ¿cuál es el número que fal­ta en el cuar­to triángulo?

Wish­ing you a hap­py and healthy summer,

The Sharp­Brains Team

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Filed Under: Brain/ Mental Health, Education & Lifelong Learning, SharpBrains Monthly eNewsletter, Technology & Innovation Tagged With: aducanumab, Aduhelm, Alzheimers-disease, anti-amyloid drug, Biogen, Brain Teasers, brain-teaser, cognitive decline, cognitive-exercise, cognitive-health, dementia, digital mental health, lifelong-brain-health, Medicare, neurodegeneration, neurotechnologies, Neurotechnology, Pear Therapeutics, retirement

Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)

June 21, 2021 by The Conversation

The U.S. Food and Drug Admin­is­tra­tion (FDA) recent­ly approved adu­canum­ab, the first treat­ment that aims to slow the pro­gres­sion of Alzheimer’s dis­ease. But approval of the drug has pro­voked mixed reac­tions from the sci­en­tif­ic community.

Alzheimer’s dis­ease is char­ac­ter­ized by pro­gres­sive mem­o­ry loss, spa­tial dis­ori­en­ta­tion and many oth­er cog­ni­tive and behav­iour­al dis­or­ders that ulti­mate­ly lead to a state of total depen­dence. [Read more…] about Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can)

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's biomarkers, Alzheimer's drug, Alzheimers-disease, amyloid, Biogen, clinical-trials, FDA, FDA drug approval process, tau

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