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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 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 856 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767311
The ClinicalTrials.gov registry entry for NCT01767311 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 856 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lecanemab 2.5 mg/kg is the first listed.
NCT01767311 reports 0 study locations.
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.
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