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Abstract Details

BAN2401 In Early Alzheimer's Disease: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With An Open-Label Extension Phase To Confirm Safety And Efficacy
Aging, Dementia, and Behavioral Neurology
P16 - Poster Session 16 (5:30 PM-6:30 PM)
10-008

To describe the study design for the ongoing CLARITY AD study.

BAN2401 is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to soluble Aβ aggregate species, while demonstrating low affinity for Aβ monomer.  An 18-month phase 2 proof-of-concept study (BAN2401-G000-201;NCT01767311) using Bayesian adaptive design was recently conducted in 856 patients with early Alzheimer’s disease (AD).  Although the primary Bayesian analysis at 12 months was not met, pre-specified 18-month frequentist analyses showed BAN2401 treatment (10mg/kg-biweekly) produced clinically meaningful reductions in clinical decline and brain amyloid burden in patients with early AD. Based on these encouraging results, a phase 3 study (BAN2401-G000-301 [CLARITY AD], NCT03887455) was designed to confirm the efficacy and safety of BAN2401 in early AD.

CLARITY AD is an 18-month treatment (core study), multicenter, double-blind, placebo-controlled, study with open-label extension (OLE) in patients with early AD.  Eligibility criteria include age 50-90 years old, MCI due to AD with intermediate likelihood or mild AD dementia with amyloid pathology confirmed by amyloid positron emission tomography (PET) or CSF assessment of t-tau/Aβ(1-42) ratio.  Patients are required to have objective impairment in episodic memory (≥1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII)). 1566 patients will be randomized across 2 treatment groups (placebo and BAN2401 10mg/kg-biweekly; 1:1 randomization).  At end of core study, patients who qualify may participate in OLE phase for up to 2 years.

The primary efficacy endpoint in core study is change in CDR-SB from baseline at 18 months. The OLE phase will evaluate long-term safety and tolerability of BAN2401 10mg/kg-biweekly in patients with early AD.

Building on positive findings from the phase 2 study, the phase 3 CLARITY AD study is designed to confirm clinical efficacy and safety of BAN2401 in patients with early AD.

Authors/Disclosures
Shau Yu Lynch (AbbVie)
PRESENTER 		Shau Yu Lynch has received personal compensation for serving as an employee of AbbVie. Shau Yu Lynch has received personal compensation for serving as an employee of Eisai. Shau Yu Lynch has stock in AbbVie.
Michael C. Irizarry, MD (Eisai, Inc) Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc..
Shobha Dhadda Shobha Dhadda has received personal compensation for serving as an employee of Eisai Inc.
Yong Zhang, MD (Renmin Hospital of Wuhan University) No disclosure on file
No disclosure on file
Tanya Bogoslovsky, MD, FÂ鶹´«Ã½Ó³»­ (Mitsubishi Tanabe Pharma Development America, Inc) Dr. Bogoslovsky has received personal compensation for serving as an employee of Eisai Inc.
Larisa Reyderman Larisa Reyderman has nothing to disclose.
No disclosure on file
No disclosure on file
Martin Rabe, MSc (Eisai Inc.) Martin Rabe, M.Sc. has received personal compensation for serving as an employee of Eisai Inc.
No disclosure on file
Lynn D. Kramer, MD, FÂ鶹´«Ã½Ó³»­ (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..
Harald Hampel Harald Hampel has received personal compensation for serving as an employee of Eisai Inc..
Chad J. Swanson Chad J Swanson has received personal compensation for serving as an employee of Eisai Inc..