amyloid

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

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

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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)

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

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6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News):

Like many peo­ple, I was shocked when the Food and Drug Admin­is­tra­tion ignored the advice of its neu­ro­log­i­cal drugs advi­so­ry pan­el and broad­ly approved Biogen’s new drug, Aduhelm, even for pop­u­la­tions nev­er includ­ed in the clin­i­cal tri­als to assess the drug. [Read more…] about First, do no harm? Six rea­sons to approach anti-amy­loid drug Aduhelm cau­tious­ly, if at all

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

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ICER Issues State­ment on the FDA’s Approval of Adu­canum­ab for Alzheimer’s Dis­ease (Insti­tute for Clin­i­cal and Eco­nom­ic Review):

The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm™, Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with known harms. [Read more…] about Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Biogen

Questionable “Alzheimer’s blood test” goes on sale prior to FDA approval

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First blood test to help diag­nose Alzheimer’s goes on sale (NBC News):

A com­pa­ny has start­ed sell­ing the first blood test to help diag­nose Alzheimer’s dis­ease, a leap for the field that could make it much eas­i­er for peo­ple to learn whether they have demen­tia. It also rais­es con­cern about the accu­ra­cy and impact of such life-alter­ing news. [Read more…] about Ques­tion­able “Alzheimer’s blood test” goes on sale pri­or to FDA approval

Update: Should candidates to high office should pass a cognitive/ mental fitness test?

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Wow, that was a cou­ple of very insight­ful dis­cus­sions, via social media no less.

#1. The first one was about whether heads of state and can­di­dates to high office should pass a cognitive/ men­tal fit­ness test. Click HERE to read and dis­cuss some of the sharpest com­ments, such as…

  • “I won­der what brought this up.”
  • “Def­i­nite­ly. We rou­tine­ly screen appli­cants for a wide range of jobs.”
  • “Then the bal­ance of polit­i­cal pow­er would shift towards the design­ers of those tests.”
  • “That’s what debates are for.”
  • “Yes, but prob­a­bly nobody would pass it.”
  • “No, because if we can’t judge that for our­selves, then what busi­ness do we have vot­ing at all?”

#2. The sec­ond debate cen­tered on the future of men­tal health: In ten years, will we see DSM‑6 or Some­thing Much Bet­ter (SMB‑1)? Would you say “Some­thing bet­ter hope­ful­ly” or “Well con­sid­er­ing we approach men­tal health from a dis­ease model.…that’s the first prob­lem” or “DSM is a tool, and a very use­ful one. As any oth­er tool it depends on the use you make of it,” or some­thing else.

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing as always new think­ing, research and tools for life­long brain health and men­tal fitness.

#3. Study: Across all ide­o­log­i­cal groups, high­er cog­ni­tive abil­i­ty and intel­lec­tu­al humil­i­ty pre­dicts sup­port for free speech

#4. Let’s under­stand how to increase resis­tance to tau and amy­loid pro­teins so we can all become “super-agers.”  Brain scans show low­er accu­mu­la­tion of tau and amy­loid pathol­o­gy among cog­ni­tive “super-agers”

#5. For exam­ple: Jobs with low phys­i­cal stress and good work­ing con­di­tions linked to larg­er hip­pocam­pus and bet­ter memory

#6. Want­ed: 30,000 vol­un­teers! Large UC study to inves­ti­gate when and how brain train­ing trans­fers (or does not) to broad­er cog­ni­tive and health benefits

#7. Time­ly ques­tions: “How com­mon are neu­ro­log­i­cal and psy­chi­atric com­pli­ca­tions in patients with COVID-19? What pro­por­tion of neu­ro­log­i­cal and psy­chi­atric com­pli­ca­tions affect the (cen­tral ner­vous sys­tem) ver­sus the periph­er­al ner­vous sys­tem, and are nov­el syn­dromes emerg­ing? And who is most at risk?” Sur­vey finds ischaemic stroke and altered men­tal sta­tus as most com­mon neu­ro­log­i­cal com­pli­ca­tions in severe COVID-19 cases

#8. “Our mind is one of the only things that we can­not con­sis­tent­ly mea­sure and quan­ti­fy. And humans do remark­able things when we can mea­sure some­thing.”  Ker­nel rais­es $53 mil­lion to ease access to rich neur­al data and mar­ket Neu­ro­science as a Ser­vice (NaaS)

#9. “We are tak­ing proven cog­ni­tive behav­ioral ther­a­pies and ful­ly automat­ing them to deliv­er the care scal­ably and con­sis­tent­ly as drugs.” Start­up Big Health rais­es $39M to uni­ver­sal­ize access to cog­ni­tive behav­ioral ther­a­py (CBT) for anx­i­ety and poor sleep

#10. Build­ing on Bill Gates’ orig­i­nal goal of ‘a com­put­er on every desk,’ per­haps it’s time for ‘real-time men­tal health sup­port on every phone.’ Microsoft announces sup­port for three inno­v­a­tive men­tal health ser­vices har­ness­ing arti­fi­cial intel­li­gence (AI)

#11. Res­o­nance. Empa­thy. Aware­ness. Com­pas­sion. Hope. And our favorite… Humor. Six tips to help reg­u­late stress lev­els in our organizations

#12. Final­ly, a fun brain teas­er. What do you see, rec­tan­gles or cir­cles?

 

Wish­ing you a good and safe August,

The Sharp­Brains Team