Expert Interview
A Second View: Discussing Biogen/Eisai’s Lecanemab Phase 3 Clarity AD results in early Alzheimer's disease
Ticker(s): BIIBInstitution: Washington University School of Medicine
- Medical Director of the Memory Diagnostic Center and Director of the Knight ADRC Clinical Trials Unit team conducting clinical therapeutic trials for people with Alzheimer disease and other dementias at WUSTL.
- Currently manages 300+ patients with memory disorder and roughly 200+ patients with Alzheimer disease.
- Research focuses on the diagnosis and treatment of neurodegenerative disorders, specifically dementing disorders; Principal Investigator for numerous clinical therapeutic trials.
Please describe your clinical practice,how many patients with Alzheimer's do you treat on a yearly basis? Tell us in short about the standard of care, and the most promising upcoming treatments.
Lecanemab is said to have reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%. Can you please give us your high-level thoughts on this important primary endpoint?
The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group. How does this compare to competition?
Dr. Lon Schneider is quoted in the press as saying the relatively low rates of brain swelling and bleeding suggest that lecanemab is easier to use than Aduhelm, and that, however, the effect “is small and would not be considered by many as a minimally clinically important difference.” Could you please share with us your insights?
Judging from the results, how likely/unlikely is it to be overturned in sensitivity analyses that look for confounding effects?
Researchers also noted the absolute difference in CDR-SB scores was small, at 0.45, with some questioning how clinically meaningful this is. What’s your take on that?
From the full dataset, what results would be most important to keep an eye on in the future: subgroup effects, (for APOE4 carriers)/ potential unblinding due to ARIA/ safety data/ biomarker findings (for tau)?
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