Lecanemab has been considered a breakthrough drug in the treatment of Alzheimer’s disease (AD). In its recent Phase III clinical trial, Clarity AD (NCT03887455), lecanemab slowed cognitive decline by 27% over the 18-month trial period, the first of its kind to do so. Despite this, there are a number of factors to consider concerning the extent of lecanemab’s clinical benefit. Alvaro Pascual-Leone, MD, PhD, Wolk Center for Memory Health, Hebrew SeniorLife & Harvard Medical School, Boston, MA; Linus Health, CMO, presents some of these considerations. For example, results from Clarity AD indicated that women showed less clinical benefit than men. It has been suggested that this could be because women tend to have more advanced tau pathology than men, making amyloid removal less effective for them. Secondly, although the slowing of decline witnessed in Clarity AD provides measurable clinical benefit, the individual patient benefit is still relatively low. On the CDR-SB scale, the results demonstrated a 0.5-point improvement. Lastly, the cost of lecanemab is predicted to be $26,500 per year, excluding the additional costs of MRI scans and biomarker assessments. Given that patients would have to pay for this out of their own pocket, the drug is inaccessible to a large percentage of the population at this stage. 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.