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CTAD 2022 | FDA approval of lecanemab: what does the data tell us about the amyloid hypothesis?

“Alvaro Pascual-Leone, MD, PhD, Wolk Center for Memory Health, Hebrew SeniorLife & Harvard Medical School, Boston, MA; Linus Health, CMO, provides his perspective on the future of lecanemab in light of its approval by the US Food and Drug Administration (FDA). In its Phase III clinical trial, Clarity AD (NCT03887455), lecanemab slowed cognitive decline in patients with early Alzheimer’s disease (AD) by 27%. The success of lecanemab in Clarity AD confirms that amyloid does contribute to the pathophysiology of AD. However, it also demonstrates that amyloid is not the only contributor. Dr Pascual-Leone argues that these results, although meaningful, do not support the amyloid hypothesis and that it will therefore be critical to approach the treatment of AD from multiple standpoints. He suggests that in the future, lecanemab may be combined with other pharmacological treatments, as well as lifestyle therapies, in order to provide the highest clinical benefit. This interview took place at the Clinical Trials on Alzheimer’s Disease Congress 2022 in San Francisco.

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Dr. A. Pascual-Leone is a co-founder and the chief medical officer of Linus Health.
He is co-founder of TI solutions and serves as a paid member of the scientific advisory boards for Neuroelectrics, Magstim Inc., TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant.
Dr. A. Pascual-Leone is partly supported by grants from the National Institutes of Health and BrightFocus Foundation. Dr. A Pascual-Leone is listed as an inventor on several issued and pending patents on the real-time integration of transcranial magnetic stimulation with electroencephalography and magnetic resonance imaging, and applications of noninvasive brain stimulation in various neurological disorders, as well as digital biomarkers of behavior.