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

Phase 2

Active, not recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: Lecanemab 10 mg/kg; Drug: Placebo; Drug: Lecanemab 5.0 mg/kg; Drug: Lecanemab 2.5 mg/kg

• Registration Number: NCT01767311
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-20
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extension Phase: Lecanemab 10 mg/kg	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).
Core Study: Lecanemab 10 mg/kg biweekly	Lecanemab 10 mg/kg	10 mg/kg biweekly
Core Study: Lecanemab 10 mg/kg monthly	Lecanemab 10 mg/kg	10 mg/kg monthly
Core Study: Lecanemab-matched Placebo	Placebo	Matching placebo biweekly
Core Study: Lecanemab 5.0 mg/kg biweekly	Lecanemab 5.0 mg/kg	5.0 mg/kg biweekly
Core Study: Lecanemab 2.5 mg/kg biweekly	Lecanemab 2.5 mg/kg	2.5 mg/kg biweekly
Core Study: Lecanemab 5.0 mg/kg monthly	Lecanemab 5.0 mg/kg	5.0 mg/kg monthly

Primary Outcome Measures

Name	Time	Method
Core Study: Change from Baseline in the Alzheimer's Disease Composite Score (ADCOMS) at 12 months	Baseline and 12 months
Core Study and Extension Phase: Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs)	From the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer; up to 78 months	Safety assessments will consist of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); safety magnetic resonance imaging (MRI); and performance of physical examinations.

Secondary Outcome Measures

Name	Time	Method
Core Study: Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) at 18 Months	Baseline and 18 Months
Core Study: Change from Baseline in Cerebrospinal fluid (CSF) Biomarkers (Aβ[1-42], t-tau, and p-tau) at 18 Months	Baseline and 18 Months
Core Study: Change from Baseline in Left and Right Hippocampal Volume at 6, 12, and 18 Months as Measured by vMRI	Baseline and 6, 12 and 18 Months
Core Study: Change from Baseline in Total Ventricular Volume at 6, 12, and 18 Months as Measured by vMRI	Baseline and 6, 12 and 18 Months
Core Study: Change from Baseline at 18 Months in Brain Amyloid Pathophysiology as Measured by Amyloid Positron Emission Tomography (PET)	Baseline and 18 Months
Core Study: Change from Baseline in the ADCOMS at 18 Months	Baseline and 18 Months
Core Study: Change from baseline at 12 months on clinical status for the following assessments: ADCOMS, CDR-SB, and ADAS-cog	Baseline and 12 Months
Core Study: Change from Baseline in CSF Biomarkers (Aβ[1-42], t-tau, and p-tau) at 12 Months	Baseline and 12 Months
Extension Phase: Percentage of Amyloid Positive Participants Over Time	Extension Phase: Baseline up to 60 months
Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months	Baseline and 18 Months
Core Study: Change from Baseline in Total Hippocampal Volume at 18 Months as Measured by Volumetric Magnetic Resonance Imaging (vMRI)	Baseline and 18 months
Core Study: Change from Baseline at 12 Months in Brain Amyloid Pathophysiology as Measured by Amyloid PET	Baseline and 12 Months
Core Study: Change from Baseline in Total Hippocampal Volume at 6 and 12 Months as Measured by vMRI	Baseline, 6 and 12 Months
Core Study: Change from Baseline in Whole Brain Volume at 6, 12, and 18 Months as Measured by vMRI	Baseline and 6, 12 and 18 Months
Change From Baselines in Brain Amyloid Levels as Measured by Amyloid PET at 3 months (Visit 50 [Extension Week 13], Cohort 1) or 6 months (Visit 57 [Extension Week 27], Cohort 2), 12 months and Annually Thereafter in the Extension Phase	Extension Phase: Baseline, 3 months (Visit 50 [Extension Week 13], Cohort 1) or 6 months (Visit 57 [Extension Week 27], Cohort 2), 12 months and annually thereafter in the Extension Phase up to Visit 174 [Extension Week 261]
Extension Phase: Change from end of Core Study in Brain Amyloid Levels as Measured by Amyloid PET at the Baseline of Extension Phase	End of Core Study (Month 18) up to Baseline of Extension Phase

Trial Locations

Locations (7)

Facility #1; 🇬🇧 Swindon, United Kingdom

Facility #2; 🇬🇧 London, United Kingdom

Facility #4; 🇰🇷 Seoul, Korea, Republic of

Eisai Trial Site #2; 🇯🇵 Shinjuku-ku, Tokyo-To, Japan

Eisai Trial Site #3; 🇯🇵 Himeji-shi, Hyogo-Ken, Japan

Eisai Trial Site #1; 🇯🇵 Shinjuku-ku, Tokyo-To, Japan

Facility #3; 🇰🇷 Seoul, Korea, Republic of