amyloid

Should doctors prescribe lecanemab (Leqembi) to women? The answer, given available evidence, is probably No

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Data from the CLARITY tri­al ear­li­er this year was sup­posed to be the crown­ing glo­ry of the amy­loid hypoth­e­sis, vin­di­ca­tion for pro­po­nents of this long-held but much-maligned the­o­ry of Alzheimer’s disease.

Yet the results left many feel­ing under­whelmed, and even the study authors noncommittal.

The CLARITY tri­al has many admirable fea­tures. It recruit­ed close to 1800 peo­ple from around the world, pret­ty bal­anced between women and men. While the major­i­ty were white, 17% of the cohort was Asian and 12% Latino.

Choice of pri­ma­ry and sec­ondary out­comes were impec­ca­ble. The pri­ma­ry out­come was the Clin­i­cal Demen­tia Rat­ing sum of box­es (CDR-SB), a score­card of sorts rat­ed by a clin­i­cian across the domains of mem­o­ry, ori­en­ta­tion, prob­lem solv­ing, com­mu­ni­ty affairs, home duties and per­son­al care. Sec­ondary out­comes includ­ed stan­dard mea­sures of glob­al cog­ni­tion, dai­ly func­tion, as well as bio­mark­ers in the brain, from the CSF and blood.

So what hap­pened? [Read more…] about Should doc­tors pre­scribe lecanemab (Leqem­bi) to women? The answer, giv­en avail­able evi­dence, is prob­a­bly No

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