A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
Phase 2
Completed
NCT01767311
| Condition | Alzheimer's Disease |
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| Phase | Phase 2 |
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| Sponsor | Eisai Inc. |
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| Status | Completed |
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| Enrollment | 856 participants |
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| Interventions | Lecanemab 2.5 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg |
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| Start date | Dec 20, 2012 |
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| Completion date | Dec 10, 2024 |
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| Results posted | Mar 4, 2026 |
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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 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: Placebo | 0.113 ± 0.012 score on a scale |
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| Core Study Phase: Lecanemab 2.5 mg/kg Biweekly | 0.134 ± 0.024 score on a scale |
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| Core Study Phase: Lecanemab 5 mg/kg Monthly | 0.119 ± 0.021 score on a scale |
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| Core Study Phase: Lecanemab 5 mg/kg Biweekly | 0.116 ± 0.016 score on a scale |
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| Core Study Phase: Lecanemab 10 mg/kg Monthly | 0.084 ± 0.011 score on a scale |
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| Core Study Phase: Lecanemab 10 mg/kg Biweekly | 0.077 ± 0.014 score on a scale |
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| Posterior Probability | 63.8 |
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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
| Core Study Phase: Placebo | 216 Participants |
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| Core Study Phase: Lecanemab 2.5 mg/kg Biweekly | 46 Participants |
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| Core Study Phase: Lecanemab 5 mg/kg Monthly | 48 Participants |
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| Core Study Phase: Lecanemab 5 mg/kg Biweekly | 81 Participants |
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| Core Study Phase: Lecanemab 10 mg/kg Monthly | 238 Participants |
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| Core Study Phase: Lecanemab 10 mg/kg Biweekly | 139 Participants |
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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
| OLE Phase: Lecanemab 10 mg/kg Biweekly | 173 Participants |
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| OLE Phase: Lecanemab 10 mg/kg Biweekly | 60 Participants |
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Open in BENITIONS
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