Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01767311 | A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease | PHASE2 | COMPLETED | 856 | — | — | Dec 20, 2012 | Dec 10, 2024 | Mar 4, 2026 | 169 | United States, Canada +9 |
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 deviation.
A TEAE is defined as an AE that emerged during treatment or within 90 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
A TEAE is defined as an AE that emerged during treatment or within 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
| Arm | Type | Description |
|---|---|---|
| Core Study: Lecanemab 2.5 mg/kg biweekly | EXPERIMENTAL | 2.5 mg/kg biweekly |
| Core Study: Lecanemab 5.0 mg/kg biweekly | EXPERIMENTAL | 5.0 mg/kg biweekly |
| Core Study: Lecanemab 10 mg/kg biweekly | EXPERIMENTAL | 10 mg/kg biweekly |
| Core Study: Lecanemab 5.0 mg/kg monthly | EXPERIMENTAL | 5.0 mg/kg monthly |
| Core Study: Lecanemab 10 mg/kg monthly | EXPERIMENTAL | 10 mg/kg monthly |
| Core Study: Lecanemab-matched Placebo | PLACEBO_COMPARATOR | Matching placebo biweekly |
| Extension Phase: Lecanemab 10 mg/kg | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| Lecanemab 2.5 mg/kg | DRUG | 2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion |
| Lecanemab 5.0 mg/kg | DRUG | 5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion |
| Lecanemab 10 mg/kg | DRUG | 10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion. |
| Placebo | DRUG | biweekly (once every 2 weeks) administered as i.v. infusion |
Key Inclusion Criteria (Core Study) for Mild Cognitive Impairment due to Alzheimer's Disease \- Intermediate likelihood: 1. Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - interme...