Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Lecanemab for the Treatment of Early Alzheimer’s Disease: The Extension of Efficacy Results from Clarity AD
Aging, Dementia, Cognitive, and Behavioral Neurology
ES1 - Emerging Science 1 (12:03 PM-12:09 PM)
009

Lecanemab is an anti-amyloid monoclonal antibody that binds with highest affinity to soluble Aβ protofibrils, which are more toxic than monomers or insoluble fibrils/plaque. In the 18-month phase 3 Clarity AD study, lecanemab demonstrated a consistent slowing of decline in clinical (global, cognitive, functional, and quality of life) outcomes, and reduction in brain amyloid in early AD.

To report the initial findings from the ongoing lecanemab Clarity AD open-label extension (OLE) study, in which we evaluated whether the treatment benefits were maintained up to 30 months in participants with early Alzheimer’s disease (AD).

Clarity AD is an 18-month, randomized study (core) in patients with early AD, with an OLE phase where eligible participants received open-label lecanemab. Clinical (CDR-SB, ADAS-Cog14, and ADCS-MCI-ADL) and biomarker (PET, Aβ42/40 ratio, and ptau181) outcomes were evaluated overall and by examining ‘delayed start’ (core:placebo followed by OLE:lecanemab) and ‘early start’ (core:lecanemab followed by OLE:lecanemab) cohorts. Analyses by core baseline tau PET levels were conducted from the tau PET sub-study.

Overall, 1385 participants enrolled in the OLE. Across clinical endpoints, lecanemab-treated participants continued to benefit through 24 months. Separation between early and delayed start was maintained between 18 and 24 months (p<0.05), with a similar disease trajectory when all participants received lecanemab. Biomarker changes continued to improve and were seen in as early as 3 months in newly-treated lecanemab participants. Across assessments, consistent rates of clinical stability or improvements were observed regardless of baseline tau levels, with the highest rates of improvements observed for the low tau group at 24 months (no decline:79%; improvement:50%). Preliminary 30-month data will be presented.

Treatment differences with ongoing lecanemab treatment through 30 months, relative to the newly treated lecanemab participants, is consistent with a disease-modifying effect. Delayed start and lower pathology group results support early initiation of treatment with lecanemab.

Authors/Disclosures
Michael Irizarry (Eisai, Inc)
PRESENTER
Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc..
Christopher van Dyck (Yale School of Medicine) Christopher van Dyck, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ono. Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Christopher van Dyck, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. An immediate family member of Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supurnus. An immediate family member of Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Polaris Management Partners. The institution of Christopher van Dyck, MD has received research support from Roche/Genentech. The institution of Christopher van Dyck, MD has received research support from Eli Lilly. The institution of Christopher van Dyck, MD has received research support from Biogen. The institution of Christopher van Dyck, MD has received research support from Biohaven. The institution of Christopher van Dyck, MD has received research support from Eisai. The institution of Christopher van Dyck, MD has received research support from UCB. The institution of Christopher van Dyck, MD has received research support from Cerevel. The institution of Christopher van Dyck, MD has received research support from Janssen.
Reisa Sperling (Brigham and Women'S Hospital) Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AC Immune. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acumen. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alector. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nervgen. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oligomerix. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prothena. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ionis. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vaxxinity. An immediate family member of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. An immediate family member of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Sperling has received research support from Eli Lilly. The institution of Dr. Sperling has received research support from Eisai. The institution of Dr. Sperling has received research support from NIH.
No disclosure on file
No disclosure on file
Steven Hersch (Eisai Inc.) Dr. Hersch has received personal compensation for serving as an employee of Eisai Inc.. Dr. Hersch has stock in Voyager Therapeutics. The institution of an immediate family member of Dr. Hersch has received research support from NIH.
Larisa Reyderman Larisa Reyderman has nothing to disclose.
Lynn Kramer (Eisai Inc.) Dr. Kramer has received personal compensation for serving as an employee of Eisai Inc.