#aducanumab — Public Fediverse posts
Live and recent posts from across the Fediverse tagged #aducanumab, aggregated by home.social.
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@Lupposofi A couple of years ago, I coauthored a paper trying to measure the applicability of the #aducanumab (#Aduhelm)'s results applied to the real world practice of a #geriatric outpatient clinic (with special focus on older persons with #cognitive impairment). Less than 1% of patients were potentially eligible. And this on the top of the unclear/arguable effects...
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@Lupposofi A couple of years ago, I coauthored a paper trying to measure the applicability of the #aducanumab (#Aduhelm)'s results applied to the real world practice of a #geriatric outpatient clinic (with special focus on older persons with #cognitive impairment). Less than 1% of patients were potentially eligible. And this on the top of the unclear/arguable effects...
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@Lupposofi A couple of years ago, I coauthored a paper trying to measure the applicability of the #aducanumab (#Aduhelm)'s results applied to the real world practice of a #geriatric outpatient clinic (with special focus on older persons with #cognitive impairment). Less than 1% of patients were potentially eligible. And this on the top of the unclear/arguable effects...
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A long-awaited AlzForum's take on the news that ApoE4 homozygotism means in fact an AD pathology (though not necessarily dementia before death), https://www.alzforum.org/news/research-news/do-two-apoe4-alleles-always-mean-alzheimers
The comments-section gives a glimpse of some of the trenchlines regarding the treatment of dementia, but I guess the prevention-camp has only just been strirred up from their Sleeping Beauty's slumber.
I, as an example, still have only a 1 % measured risk of acquiring AD, according to some widely used screens, and no "preventable risk factors" except maybe age. Too bad, my genetic inheritance seems to have been enough to skew the Amyloid-Beta balance early on. Luckily, I was recruited to the aducanumab-study for four years (a precursor of lecanemab with more severe side-effects), and probably got some more years to be able to think things like these.
#alzheimer #research #medical #APOE4 #alzForum #dementia #ad #alzheimers #amyloid #lecanemab #aducanumab #prevention #cure
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A long-awaited AlzForum's take on the news that ApoE4 homozygotism means in fact an AD pathology (though not necessarily dementia before death), https://www.alzforum.org/news/research-news/do-two-apoe4-alleles-always-mean-alzheimers
The comments-section gives a glimpse of some of the trenchlines regarding the treatment of dementia, but I guess the prevention-camp has only just been strirred up from their Sleeping Beauty's slumber.
I, as an example, still have only a 1 % measured risk of acquiring AD, according to some widely used screens, and no "preventable risk factors" except maybe age. Too bad, my genetic inheritance seems to have been enough to skew the Amyloid-Beta balance early on. Luckily, I was recruited to the aducanumab-study for four years (a precursor of lecanemab with more severe side-effects), and probably got some more years to be able to think things like these.
#alzheimer #research #medical #APOE4 #alzForum #dementia #ad #alzheimers #amyloid #lecanemab #aducanumab #prevention #cure
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A long-awaited AlzForum's take on the news that ApoE4 homozygotism means in fact an AD pathology (though not necessarily dementia before death), https://www.alzforum.org/news/research-news/do-two-apoe4-alleles-always-mean-alzheimers
The comments-section gives a glimpse of some of the trenchlines regarding the treatment of dementia, but I guess the prevention-camp has only just been strirred up from their Sleeping Beauty's slumber.
I, as an example, still have only a 1 % measured risk of acquiring AD, according to some widely used screens, and no "preventable risk factors" except maybe age. Too bad, my genetic inheritance seems to have been enough to skew the Amyloid-Beta balance early on. Luckily, I was recruited to the aducanumab-study for four years (a precursor of lecanemab with more severe side-effects), and probably got some more years to be able to think things like these.
#alzheimer #research #medical #APOE4 #alzForum #dementia #ad #alzheimers #amyloid #lecanemab #aducanumab #prevention #cure
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An expected news from Alzheimer therapies, https://www.alzforum.org/news/community-news/adieu-aduhelm-biogen-stops-marketing-antibody
A bit nostalgic, though, because I was one of the few whose cognition improved (relatively, i.e. compared to the control-group) during the years I got the antibody 10 mg / kg, enough for Biogen to apply for license.
It was a marvellous box-seat to observe pharmaceutical research with all it's intricacies, and live neurological expertise within an arm's reach was invaluable.
Here is the history of aducanumab, rest in pieces, https://www.alzforum.org/therapeutics/aduhelm
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An expected news from Alzheimer therapies, https://www.alzforum.org/news/community-news/adieu-aduhelm-biogen-stops-marketing-antibody
A bit nostalgic, though, because I was one of the few whose cognition improved (relatively, i.e. compared to the control-group) during the years I got the antibody 10 mg / kg, enough for Biogen to apply for license.
It was a marvellous box-seat to observe pharmaceutical research with all it's intricacies, and live neurological expertise within an arm's reach was invaluable.
Here is the history of aducanumab, rest in pieces, https://www.alzforum.org/therapeutics/aduhelm
-
An expected news from Alzheimer therapies, https://www.alzforum.org/news/community-news/adieu-aduhelm-biogen-stops-marketing-antibody
A bit nostalgic, though, because I was one of the few whose cognition improved (relatively, i.e. compared to the control-group) during the years I got the antibody 10 mg / kg, enough for Biogen to apply for license.
It was a marvellous box-seat to observe pharmaceutical research with all it's intricacies, and live neurological expertise within an arm's reach was invaluable.
Here is the history of aducanumab, rest in pieces, https://www.alzforum.org/therapeutics/aduhelm
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"I think one of the reasons Leqembi was approved (and Lilly's donanemab is likely to be, this year) is that aducanumab was approved. I remain skeptical that these drugs will provide any real-world benefit, but I am not skeptical at all of the sales potentials for both of them."
#Alzheimer
#Leqembi
#aducanumabhttps://www.science.org/content/blog-post/goodbye-aduhelm?s=09
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"I think one of the reasons Leqembi was approved (and Lilly's donanemab is likely to be, this year) is that aducanumab was approved. I remain skeptical that these drugs will provide any real-world benefit, but I am not skeptical at all of the sales potentials for both of them."
#Alzheimer
#Leqembi
#aducanumabhttps://www.science.org/content/blog-post/goodbye-aduhelm?s=09
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"I think one of the reasons Leqembi was approved (and Lilly's donanemab is likely to be, this year) is that aducanumab was approved. I remain skeptical that these drugs will provide any real-world benefit, but I am not skeptical at all of the sales potentials for both of them."
#Alzheimer
#Leqembi
#aducanumabhttps://www.science.org/content/blog-post/goodbye-aduhelm?s=09
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"I think one of the reasons Leqembi was approved (and Lilly's donanemab is likely to be, this year) is that aducanumab was approved. I remain skeptical that these drugs will provide any real-world benefit, but I am not skeptical at all of the sales potentials for both of them."
#Alzheimer
#Leqembi
#aducanumabhttps://www.science.org/content/blog-post/goodbye-aduhelm?s=09
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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
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Diese Innovation bringt ein Alzheimer-Medikament durch die Blut-Hirn-Schranke | heise online
https://heise.de/-9600712 #Alzheimer #Ultraschall #Aducanumab #BlutHirnSchranke -
Diese Innovation bringt ein Alzheimer-Medikament durch die Blut-Hirn-Schranke | heise online
https://heise.de/-9600712 #Alzheimer #Ultraschall #Aducanumab #BlutHirnSchranke -
Diese Innovation bringt ein Alzheimer-Medikament durch die Blut-Hirn-Schranke | heise online
https://heise.de/-9600712 #Alzheimer #Ultraschall #Aducanumab #BlutHirnSchranke -
Diese Innovation bringt ein Alzheimer-Medikament durch die Blut-Hirn-Schranke | heise online
https://heise.de/-9600712 #Alzheimer #Ultraschall #Aducanumab #BlutHirnSchranke -
Alzheimer’s disease is a devastating form of dementia affecting millions worldwide. A new drug, called aducanumab, has been approved by the FDA for treating Alzheimer’s. The drug works by clearing the toxic amyloid plaques that build up in the brain and cause memory loss. Many reports appeared last year disputing the amyloid hypothesis. The success of similar drugs in the past has been dismal.
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Alzheimer’s disease is a devastating form of dementia affecting millions worldwide. A new drug, called aducanumab, has been approved by the FDA for treating Alzheimer’s. The drug works by clearing the toxic amyloid plaques that build up in the brain and cause memory loss. Many reports appeared last year disputing the amyloid hypothesis. The success of similar drugs in the past has been dismal.
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Alzheimer’s disease is a devastating form of dementia affecting millions worldwide. A new drug, called aducanumab, has been approved by the FDA for treating Alzheimer’s. The drug works by clearing the toxic amyloid plaques that build up in the brain and cause memory loss. Many reports appeared last year disputing the amyloid hypothesis. The success of similar drugs in the past has been dismal.
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Alzheimer’s disease is a devastating form of dementia affecting millions worldwide. A new drug, called aducanumab, has been approved by the FDA for treating Alzheimer’s. The drug works by clearing the toxic amyloid plaques that build up in the brain and cause memory loss. Many reports appeared last year disputing the amyloid hypothesis. The success of similar drugs in the past has been dismal.
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Ein Bericht von zwei Komitees des US-amerikanischen Repräsentantenhauses erhebt schwere Vorwürfe gegen die Zulassungsbehörde FDA im Zusammenhang mit dem umstrittenen Alzheimer-Medikament #Aducanumab.
https://gutepillen-schlechtepillen.de/aducanumab-bei-alzheimer-kritik-an-fda/
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Ein Bericht von zwei Komitees des US-amerikanischen Repräsentantenhauses erhebt schwere Vorwürfe gegen die Zulassungsbehörde FDA im Zusammenhang mit dem umstrittenen Alzheimer-Medikament #Aducanumab.
https://gutepillen-schlechtepillen.de/aducanumab-bei-alzheimer-kritik-an-fda/
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Ein Bericht von zwei Komitees des US-amerikanischen Repräsentantenhauses erhebt schwere Vorwürfe gegen die Zulassungsbehörde FDA im Zusammenhang mit dem umstrittenen Alzheimer-Medikament #Aducanumab.
https://gutepillen-schlechtepillen.de/aducanumab-bei-alzheimer-kritik-an-fda/
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FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):
https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/
CMS will still need to decide about Medicare coverage.
Eisai expected to seek full FDA approval based on additional cognitive outcomes data.
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FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):
https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/
CMS will still need to decide about Medicare coverage.
Eisai expected to seek full FDA approval based on additional cognitive outcomes data.
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FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):
https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/
CMS will still need to decide about Medicare coverage.
Eisai expected to seek full FDA approval based on additional cognitive outcomes data.
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FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):
https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/
CMS will still need to decide about Medicare coverage.
Eisai expected to seek full FDA approval based on additional cognitive outcomes data.
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"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."
#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab
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"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."
#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab
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"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."
#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab
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Update on #aducanumab fiasco:
Congressional investigation into regulatory capture of the FDA is damning:
FDA's approval process was "rife with irregularities"
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Update on #aducanumab fiasco:
Congressional investigation into regulatory capture of the FDA is damning:
FDA's approval process was "rife with irregularities"
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Update on #aducanumab fiasco:
Congressional investigation into regulatory capture of the FDA is damning:
FDA's approval process was "rife with irregularities"
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Update on #aducanumab fiasco:
Congressional investigation into regulatory capture of the FDA is damning:
FDA's approval process was "rife with irregularities"
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TL;DR:
#Lecanemab, like #aducanumab, only slightly effective in delaying cognitive decline in people with #Alzheimers disease.
Seems to be better tolerated than aducanumab.
Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.
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TL;DR:
#Lecanemab, like #aducanumab, only slightly effective in delaying cognitive decline in people with #Alzheimers disease.
Seems to be better tolerated than aducanumab.
Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.
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TL;DR:
#Lecanemab, like #aducanumab, only slightly effective in delaying cognitive decline in people with #Alzheimers disease.
Seems to be better tolerated than aducanumab.
Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.
-
TL;DR:
#Lecanemab, like #aducanumab, only slightly effective in delaying cognitive decline in people with #Alzheimers disease.
Seems to be better tolerated than aducanumab.
Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.
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As with #aducanumab trials EMERGE/ENGAGE, Black people were underrepresented:
20/859 lecanemab (2.3%)
24/875 placebo (2.7%)The effect on applying the results to clinical practice are immediately apparent in the attached graph:
Whereas cognitive effects of #lecanemab were statistically significant in White study participants, cognitive effects were NOT statistically significant in Black study participants.
The study was underpowered to demonstrate effect in Black people with #Alzheimers.
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As with #aducanumab trials EMERGE/ENGAGE, Black people were underrepresented:
20/859 lecanemab (2.3%)
24/875 placebo (2.7%)The effect on applying the results to clinical practice are immediately apparent in the attached graph:
Whereas cognitive effects of #lecanemab were statistically significant in White study participants, cognitive effects were NOT statistically significant in Black study participants.
The study was underpowered to demonstrate effect in Black people with #Alzheimers.
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As with #aducanumab trials EMERGE/ENGAGE, Black people were underrepresented:
20/859 lecanemab (2.3%)
24/875 placebo (2.7%)The effect on applying the results to clinical practice are immediately apparent in the attached graph:
Whereas cognitive effects of #lecanemab were statistically significant in White study participants, cognitive effects were NOT statistically significant in Black study participants.
The study was underpowered to demonstrate effect in Black people with #Alzheimers.
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As with #aducanumab trials EMERGE/ENGAGE, Black people were underrepresented:
20/859 lecanemab (2.3%)
24/875 placebo (2.7%)The effect on applying the results to clinical practice are immediately apparent in the attached graph:
Whereas cognitive effects of #lecanemab were statistically significant in White study participants, cognitive effects were NOT statistically significant in Black study participants.
The study was underpowered to demonstrate effect in Black people with #Alzheimers.
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Tolerability of #lecanemab seems to be better than that of #aducanumab (though this wasn't a head-to-head comparison, so we can't be sure):
- infusion-related reactions: 26.4% lecanemab vs 7.4% placebo, usually with first infusion and usually mild
- ARIA-H: 17.3% vs 9.0%
- ARIA-E: 12.6% vs 1.7%There were 6 deaths (0.7%) reported with lecanemab vs 7 (0.8%) with placebo.
Note, however, recent reports of two deaths in people receiving lecanemab:
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Tolerability of #lecanemab seems to be better than that of #aducanumab (though this wasn't a head-to-head comparison, so we can't be sure):
- infusion-related reactions: 26.4% lecanemab vs 7.4% placebo, usually with first infusion and usually mild
- ARIA-H: 17.3% vs 9.0%
- ARIA-E: 12.6% vs 1.7%There were 6 deaths (0.7%) reported with lecanemab vs 7 (0.8%) with placebo.
Note, however, recent reports of two deaths in people receiving lecanemab:
-
Tolerability of #lecanemab seems to be better than that of #aducanumab (though this wasn't a head-to-head comparison, so we can't be sure):
- infusion-related reactions: 26.4% lecanemab vs 7.4% placebo, usually with first infusion and usually mild
- ARIA-H: 17.3% vs 9.0%
- ARIA-E: 12.6% vs 1.7%There were 6 deaths (0.7%) reported with lecanemab vs 7 (0.8%) with placebo.
Note, however, recent reports of two deaths in people receiving lecanemab:
-
Tolerability of #lecanemab seems to be better than that of #aducanumab (though this wasn't a head-to-head comparison, so we can't be sure):
- infusion-related reactions: 26.4% lecanemab vs 7.4% placebo, usually with first infusion and usually mild
- ARIA-H: 17.3% vs 9.0%
- ARIA-E: 12.6% vs 1.7%There were 6 deaths (0.7%) reported with lecanemab vs 7 (0.8%) with placebo.
Note, however, recent reports of two deaths in people receiving lecanemab:
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As with #aducanumab, #lecanemab demonstrated remarkable clearing of #amyloid.
This further calls into doubt the relationship between amyloid reduction and cognitive improvement.
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As with #aducanumab, #lecanemab demonstrated remarkable clearing of #amyloid.
This further calls into doubt the relationship between amyloid reduction and cognitive improvement.
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As with #aducanumab, #lecanemab demonstrated remarkable clearing of #amyloid.
This further calls into doubt the relationship between amyloid reduction and cognitive improvement.
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As with #aducanumab, #lecanemab demonstrated remarkable clearing of #amyloid.
This further calls into doubt the relationship between amyloid reduction and cognitive improvement.
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The first peer-reviewed results of #lecanemab for #Alzheimers disease are now out:
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
Bottom line:
- very modest cognitive benefit: 0.45 difference between lecanemab & placebo on an 18-point scale (CDR-SB) over 18 months
- fair amount of side effects, including ARIA-H, ARIA-E & infusion reactions (though appear to be fewer than with #aducanumab). -
The first peer-reviewed results of #lecanemab for #Alzheimers disease are now out:
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
Bottom line:
- very modest cognitive benefit: 0.45 difference between lecanemab & placebo on an 18-point scale (CDR-SB) over 18 months
- fair amount of side effects, including ARIA-H, ARIA-E & infusion reactions (though appear to be fewer than with #aducanumab). -
The first peer-reviewed results of #lecanemab for #Alzheimers disease are now out:
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
Bottom line:
- very modest cognitive benefit: 0.45 difference between lecanemab & placebo on an 18-point scale (CDR-SB) over 18 months
- fair amount of side effects, including ARIA-H, ARIA-E & infusion reactions (though appear to be fewer than with #aducanumab). -
The first peer-reviewed results of #lecanemab for #Alzheimers disease are now out:
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
Bottom line:
- very modest cognitive benefit: 0.45 difference between lecanemab & placebo on an 18-point scale (CDR-SB) over 18 months
- fair amount of side effects, including ARIA-H, ARIA-E & infusion reactions (though appear to be fewer than with #aducanumab). -
FDA officials asked to step down after contentious Alzheimer’s drug approval - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1774338 #alzheimersdrug #publiccitizen #drugapproval #aducanumab #science #aduhelm #biogen #fda