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NCT01767311 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 856
- Enrollment target
NCT01767311: Completed Phase 2 study, sponsored by Eisai.
NCT01767311 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 856 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (544% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767311, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 856 participants
- Enrollment target
Study 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.
Primary Outcome
The ADCOMS is a composite score that comprises 4/14 items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), 2 items from the Mini Mental State Examination (MMSE), and all items from the Clinical Dementia Rating (CDR). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment. Change from baseline was analyzed using Bayesian analysis. Data presented are posterior mean and posterior standard de
Interventions
- DRUG Lecanemab 2.5 mg/kg
- DRUG Lecanemab 5.0 mg/kg
- DRUG Lecanemab 10 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 856 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2024-12-10 |
| Phase | Phase 2 |
What the finished NCT01767311 record still lists
NCT01767311 is an interventional study that assigns participants to a tested intervention. The registered 856 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (544% higher).
The record links to 0 conditions, and to 3 interventions - of which Lecanemab 2.5 mg/kg is the first listed.
NCT01767311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01767311 about?
NCT01767311 is a clinical study titled "A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease". 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 clinic...
What is the current status of trial NCT01767311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 856 participants. The study started on 2012-12-20. Estimated completion is 2024-12-10.
What interventions are being tested in trial NCT01767311?
The interventions under investigation include: Lecanemab 2.5 mg/kg (DRUG), Lecanemab 5.0 mg/kg (DRUG), Lecanemab 10 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01767311?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01767311's enrollment target sits among peer trials
856 35th of 2000 higher than 1,966 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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