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Abstract Details

Impact of Clinical Subgroup and Baseline Amyloid PET Centiloid Levels on Occurrence of ARIA in the Lecanemab Phase 3 Clarity AD Study in Early Alzheimer’s Disease
Aging, Dementia, and Behavioral Neurology
P1 - Poster Session 1 (8:00 AM-9:00 AM)
9-007
To evaluate the frequency of amyloid-related imaging abnormalities due to edema (ARIA-E) and hemosiderin deposition (ARIA-H) in key subgroups of the Clarity AD trial, including by baseline amyloid PET centiloid levels and by clinical subgroup (mild cognitive impairment [MCI] and mild Alzheimer’s disease [mAD]).
In multiple early Alzheimer’s disease clinical trials, lecanemab, an approved amyloid beta-directed antibody that selectively targets protofibrils, has been shown to be well tolerated, with an increase in ARIA-E and ARIA-H relative to placebo. This presentation reports ARIA occurrences in key clinical and biomarker subgroups. 

Clarity AD was a 18-month, phase 3 study in which eligible patients are randomized 1:1 across 2 treatment groups (placebo and lecanemab 10 mg/kg biweekly). ARIA occurrence was monitored throughout the study by central reading of magnetic resonance imaging. ARIA occurrence was evaluated in the following subgroups: by baseline centiloid tertiles (low:≤68.185, middle:>68.185-101.245, and highest:>101.245) and clinical subgroup (MCI and mAD). 
Overall, 1107 patients were MCI (lecanemab:552; placebo:555) and 688 patients were mAD (lecanemab:346; placebo:342). When evaluating ARIA-E in subgroups based on baseline centiloid tertiles, the event rates were 8.5% and 3.3% for the low tertile, 15.3% and 1.6% in the middle tertile, and 13.4% and 0.9% in the highest tertile for the lecanemab and placebo groups, respectively. No trends were observed for ARIA-H. ApoE4 zygosity did not impact results across subgroups. In the clinical subgroup analysis, ARIA-E rates were 12.7% and 1.4% for MCI patients and 12.4% and 2.1% for mild AD patients in the placebo and lecanemab groups, respectively. The event rates of ARIA-H were similar between patients with MCI and mild AD.
The frequency of ARIA-E in the Clarity AD trial was similar when evaluated by baseline amyloid PET tertile centiloid levels and by clinical subgroup. No trends were observed for ARIA-H. 
Authors/Disclosures
Marwan N. Sabbagh, MD, FAAN (Barrow Neurological Institute)
PRESENTER 		Dr. Sabbagh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech=Roche. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novo Nordisk. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Sabbagh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaptogenix. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant Health. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Anavex. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cognito Therapeutics. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for CervoMed. Dr. Sabbagh has stock in Neurotau. Dr. Sabbagh has stock in Seq Biomarque. Dr. Sabbagh has stock in uMethod Health. Dr. Sabbagh has stock in Athira. Dr. Sabbagh has stock in Lighthouse Pharmaceuticals. Dr. Sabbagh has stock in Alzheon. The institution of Dr. Sabbagh has received research support from NIH. The institution of Dr. Sabbagh has received research support from ADDF.
David Li (Eisai) David Li has received personal compensation for serving as an employee of Eisai.
Shobha Dhadda Shobha Dhadda has received personal compensation for serving as an employee of Eisai Inc.
Steven M. Hersch, MD, PhD (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. Dr. Hersch has received intellectual property interests from a discovery or technology relating to health care.
Luigi Giorgi, MD No disclosure on file
Andre P. Matta, MD (Eisai) Dr. Matta has received personal compensation for serving as an employee of Sanofi. Dr. Matta has received stock or an ownership interest from Sanofi.
Michael C. Irizarry, MD (Eisai, Inc) Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc..
Lynn D. Kramer, MD, FAAN (Eisai Inc.) Dr. Kramer has received personal compensation for serving as an employee of Eisai Inc. Dr. Kramer has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Eisai Co., Ltd..