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

Summary

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 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.

Conditions

• Alzheimer's Disease

Interventions

DRUG

Lecanemab 10 mg/kg

10 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401

DRUG

Placebo

biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 10 mg/kg

10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.

DRUG

Lecanemab 2.5 mg/kg

2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 5.0 mg/kg

5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 10 mg/kg

10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.

DRUG

Lecanemab 5.0 mg/kg

5.0 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401

Sponsors & Collaborators

• Biogen

  collaborator INDUSTRY

• Eisai Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-20

Primary Completion

2024-12-10

Completion

2024-12-10

FDA Drug

Yes

Countries

• United States
• Canada
• France
• Germany
• Italy
• Japan
• Netherlands
• South Korea
• Spain
• Sweden
• United Kingdom

Study Locations