BASELINE CHARACTERISTICS FOR CLARITY-AD: A PHASE 3 PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL-GROUP, 18-MONTH STUDY EVALUATING BAN2401 IN EARLY ALZHEIMER’S DISEASE (3021)

Objective: To describe the baseline characteristics for subjects in the ongoing CLARITY AD study. Background: BAN2401 is a humanized IgG1 monoclonal antibody that selectively targets soluble aggregated Aβ species. Based on encouraging results from a phase 2 study, the CLARITY AD phase 3 study was designed to confirm the efficacy and safety of BAN2401 in patients with early Alzheimer’s disease. Design/Methods: CLARITY AD is an 18-month treatment, multicenter, double-blind, placebo-controlled, parallel-group study with open-label extension in patients with early AD. Baseline clinical and demographic data was summarized descriptively and compared to the BAN2401 phase 2 study population. Results: As of a data cutoff of June 22, 2020, a total of 801 subjects were enrolled in CLARITY AD. The median age of subjects was 73 years (range: 50–89 years), with 83% of patients 65 years of age or older. Overall, 51% of subjects were female and 78% were Caucasian. Mean (SD) baseline values for clinical endpoints were 3.3 (1.3) for CDR-SB, 0.4 (0.1) for ADCOMS, 25.2 (7.2) for ADAS-Cog, 25.6 (2.2) for MMSE, and 0.6 (0.2) for Global CDR. Aggregate baseline characteristics are similar to the BAN2401 phase 2 study (median age 72 years [range: 50–90 years]; 80% 65 years of age or older; 50% female; 90% Caucasian; clinical endpoints: 3.0 [1.4] for CDR-SB, 0.4 [0.2] for ADCOMS, 22.2 [7.4] for ADAS-Cog, 25.6 [2.4] for MMSE, and 0.6 [0.2] for Global CDR). Comparisons of the study populations will be presented. Conclusions: Building on the encouraging findings from the BAN2401 phase 2 study, the phase 3 CLARITY AD study is designed to confirm clinical efficacy and safety of BAN2401 versus placebo in patients with early AD. Baseline characteristics after enrollment of 801 subjects are consistent with previous studies and representative of an early AD population. Enrollment is ongoing. Disclosure: Shau Yu Lynch has received personal compensation for serving as an employee of Eisai. Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc.. Shobha Dhadda has received personal compensation for serving as an employee of Eisai Inc. Dr. Bogoslovsky has received personal compensation for serving as an employee of Eisai Inc. Larisa Reyderman has nothing to disclose. June Kaplow has received personal compensation for serving as an employee of Eisai Inc.. June Kaplow has a non-compensated relationship as a Participant member with ADNI that is relevant to AAN interests or activities. Martin Rabe, M.Sc. has received personal compensation for serving as an employee of Eisai Inc. Dr. Kramer has received personal compensation for serving as an employee of Eisai Inc. Harald Hampel has received personal compensation for serving as an employee of Eisai Inc.. Chad J Swanson has nothing to disclose.