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amyloid

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

May 10, 2023 by Prof. Michael Valenzuela

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

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Filed Under: Brain/ Mental Health Tagged With: amyloid, amyloid antibodies, amyloid removal, CLARITY trial, Clinical Dementia Rating, immunotherapy, lecanemab, Leqembi, women

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

February 28, 2023 by SharpBrains

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

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's drug, Alzheimers-Association, amyloid, CMS, dementia, FDA, lecanemab, Leqembi, Medicare, monoclonal antibodies

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

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

June 16, 2021 by SharpBrains

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

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Filed Under: Brain/ Mental Health Tagged With: Aduhelm, amyloid, anti-amyloid, dementia, FDA, Food and Drug Administration, neurological drugs

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

June 14, 2021 by SharpBrains

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

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer’s Disease, Alzheimer’s disease treatment, amyloid, amyloid plaques, amyloid-related imaging abnormalities, ARIA, Biogen, brain, brain swelling, clinical benefit, FDA, ICER, Janet Woodcock, Neurons, serious side effects, tangles, tau

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

December 1, 2020 by SharpBrains

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

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Filed Under: Brain/ Mental Health Tagged With: Alzheimer's blood test, Alzheimer’s Disease, amyloid, amyloid buildup, amyloid hypothesis, blood-test, dementia, FDA, Food and Drug Administration

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