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Lecanemab in Early Alzheimer's Disease
Christopher H van Dyck1, Chad J Swanson1, Paul Aisen1
1From the Alzheimer's Disease Research Unit, Yale School of Medicine, New Haven, CT (C.H.D.); Eisai, Nutley, NJ (C.J.S., M.K., D.L., L.R., S.D., M.I., L.D.K.); the Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (P.A.); Washington University School of Medicine in St. Louis, St. Louis (R.B.); the Memory, Aging, and Cognition Center, Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore (C.C.); Eisai, Hatfield, United Kingdom (M.G.); Toronto Memory Program, Toronto (S.C.); Medical Faculty Mannheim, University of Heidelberg, Central Institute of Mental Health, Mannheim, Germany (L.F.); Katayama Medical Clinic, Okayama (S.K.), and the Department of Neuropathology, Graduate School of Medicine, University of Tokyo, and the National Center of Neurology and Psychiatry, Tokyo (T.I.) - all in Japan; Barrow Neurological Institute, Phoenix, AZ (M.S.); Toulouse Gerontopole University Hospital, Université Paul Sabatier, INSERM Unité 1295, Toulouse, France (B.V.); and Alzheimer's Research and Treatment Center, Wellington, FL (D.W.).
Lecanemab, an Alzheimer's disease treatment, moderately reduced cognitive and functional decline by targeting amyloid-beta plaques. While effective, it was associated with adverse events requiring further study.
Area of Science:
- Neurology
- Pharmacology
- Biochemistry
Background:
- Accumulation of aggregated amyloid-beta (Aβ) is implicated in Alzheimer's disease (AD) pathogenesis.
- Lecanemab is a monoclonal antibody targeting Aβ soluble protofibrils.
Purpose of the Study:
- To evaluate the efficacy and safety of lecanemab in early Alzheimer's disease.
- To assess lecanemab's effect on cognitive and functional decline and amyloid burden.
Main Methods:
- An 18-month, double-blind, placebo-controlled, phase 3 trial (Clarity AD) was conducted.
- Participants with early AD received intravenous lecanemab or placebo.
- Primary endpoint: change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score.
Main Results:
- Lecanemab showed a statistically significant reduction in CDR-SB score compared to placebo (difference, -0.45; P<0.001).
- Lecanemab significantly reduced brain amyloid burden on PET scans.
- Improvements were observed in secondary endpoints including ADAS-cog14, ADCOMS, and ADCS-MCI-ADL scores, favoring lecanemab.
Conclusions:
- Lecanemab demonstrated moderate efficacy in slowing cognitive and functional decline in early AD.
- Adverse events, including infusion-related reactions and ARIA, were observed.
- Further long-term studies are necessary to confirm lecanemab's efficacy and safety profile.
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