At a glance
ClinicalIndex Comparison Record- ✓Meets NIA-AA criteria for mild cognitive impairment due to AD (intermediate likelihood) OR mild AD dementia
- ✓CDR score 0.5–1.0 and Memory Box score ≥0.5
- ✓Objective memory impairment: WMS-IV Logical Memory II ≤age-adjusted cutoff (≤15 for age 50–64, ≤12 for 65–69, ≤11 for 70–74, ≤9 for 75–79, ≤7 for 80–90)
- ✓Positive amyloid biomarker by PET or CSF (Aβ1-42)
- ✕Any neurological condition contributing to cognitive impairment beyond AD
- ✕History of TIA, stroke, or seizures within 12 months of screening
- ✕Psychiatric diagnosis or symptoms (hallucinations, major depression, delusions) interfering with study procedures
- ✕GDS score ≥8
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating Lecanemab 2.5 mg/kg, Lecanemab 5.0 mg/kg, and 2 other interventions for Alzheimer's Disease. Completed, enrolled 856 participants across 169 sites in 11 countries.
Detailed 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.
Study Details
Timeline
Interventions
2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
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
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
biweekly (once every 2 weeks) administered as i.v. infusion
10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.