A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

第2相 完了 NCT01767311

概要

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 \[Week 79\] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 month

Core Study Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at Month 12

Core Study Phase: at Month 12 · score on a scale

Core Study Phase: Number of Participants With All Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

From first dose of the study drug (Week 1) up to 90 days after last dose of study drug (up to 21 months) · Participants

OLE Phase: Number of Participants With All TEAEs and SAEs

From first dose of the study drug (Week 1) up to 30 days after last dose of study drug (up to 61 months) · Participants

BENITIONS で見る ClinicalTrials.gov の原文を見る

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