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

Conditions

• Alzheimer's Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Lecanemab 2.5 mg/kg — DRUG
  2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
• Lecanemab 5.0 mg/kg — DRUG
  5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
• Lecanemab 10 mg/kg — DRUG
  10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
• Lecanemab 5.0 mg/kg — DRUG
  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
• Lecanemab 10 mg/kg — DRUG
  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
• Placebo — DRUG
  biweekly (once every 2 weeks) administered as i.v. infusion
• Lecanemab 10 mg/kg — DRUG
  10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.

Study Details

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.

Key Dates

Start date

Dec 20, 2012

Status verified

Jan 2026

Primary completion

Dec 10, 2024

Completion

Dec 10, 2024

Study Design

Enrollment

856 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Core Study: Lecanemab 2.5 mg/kg biweekly
  2.5 mg/kg biweekly
• Experimental: Core Study: Lecanemab 5.0 mg/kg biweekly
  5.0 mg/kg biweekly
• Experimental: Core Study: Lecanemab 10 mg/kg biweekly
  10 mg/kg biweekly
• Experimental: Core Study: Lecanemab 5.0 mg/kg monthly
  5.0 mg/kg monthly
• Experimental: Core Study: Lecanemab 10 mg/kg monthly
  10 mg/kg monthly
• Placebo Comparator: Core Study: Lecanemab-matched Placebo
  Matching placebo biweekly
• Experimental: Extension Phase: Lecanemab 10 mg/kg
  All participants who fulfill Extension Phase inclusion and exclusion criteria will have the option to participate in the Extension Phase to receive lecanemab 10 mg/kg biweekly for up to 60 months or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. Additionally, participants who have received Extension Phase treatment for at least 18 months may opt to enter the dosing regimen substudy during which they will receive either lecanemab 10 mg/kg once every 4 weeks (Q4W) or once every 3 months (Q3M).

Primary Outcome Measure

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

Locations (91)

Related coverage on Hipa.ai

• Lecanemab Trial Shows Lower ADCOMS Scores in Early Alzheimer's Disease
  Lecanemab · Mar 4, 2026 · ClinicalTrials.gov

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