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Accelerated Brain Volume Loss Caused by Anti–β-Amyloid Drugs: A Systematic Review and Meta-analysis

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Accelerated Brain Volume Loss Caused by Anti–β-Amyloid Drugs: A Systematic Review and Meta-analysis | Neurology


https://n.neurology.org/content/early/2023/03/24/WNL.0000000000207156


Meta-analysis finds troubling side effect to antiamyloid drugs
A meta-analysis published in Neurologyfound that Alzheimer's disease drugs targeting amyloid beta peptides might accelerate loss of brain volume -- a phenomenon that has been observed in clinical trial participants. Researchers also found an association between antiamyloid antibodies but not secretase inhibitors, and increase in brain ventricle size indicative of extra fluid caused by atrophy of surrounding brain tissue.
Full Story: Science (tiered subscription model) (3/28)
 

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Conclusions: These findings reveal the potential for anti-Aβ therapies to compromise long-term brain health by accelerating brain atrophy, and provide new insight into the adverse impact of ARIA. Six recommendations emerge from these findings.
 




















As described in this Science article published 28th March 2023, there are serious safety concerns of brain shrinkage and what it means for cognitive decline in individual patient receiving lecanemab over time.

On the efficacy side, Eisai/Biogen are doing their best to mislead Wall Street Analysts and the scientific and medical communities by touting a published “reanalysis” of the Phase IIb data as showing “clinical efficacy” of lecanemab.

The lecanemab (LEQEMBI) label agreed by Biogen/Eisai and approved by the FDA is clear about this Phase IIb study: Clinical efficacy was NEGATIVE, described in the label as follows:

“The primary endpoint was change from baseline on a weighted composite score consisting of selected items from the CDR-SB, MMSE, and ADAS-Cog14 at Week 53. LEQEMBI had a 64% likelihood of 25% or greater slowing of progression on the primary endpoint relative to placebo at Week 53, which did not meet the prespecified success criterion of 80%.”