Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lecanemab · 2 trials · 3 indications
PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0\[worst\]-96\[best recall\]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0\[worst\]-25\[best recall\]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0\[none\]-91\[best performance\]);Mini Mental State Score:to evaluate orientation,memory,attention,concentration,naming,repetition,comprehension and ability to create sentence,to copy 2 overlapping pentagons, scored as number of correctly completed items(0\[worse\]-30\[perfect performance\]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).
A TEAE is defined as an adverse event (AE) that emerges during treatment or within 30 days of the last dose of study drug, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) will be reported based on their regular measurement of vital signs, safety assessments of laboratory tests, antidrug antibody assessments, suicidality assessments, magnetic resonance imaging and electrocardiogram parameter values.
| Arm | Type | Description |
|---|---|---|
| A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) | EXPERIMENTAL | Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study. |
| A45 Trial: Placebo (Core Study) | PLACEBO_COMPARATOR | Participants will receive placebo (0.9 percent \[%\] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216. |
| A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) | EXPERIMENTAL | Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study. |
| A3 Trial: Placebo (Core Study) | PLACEBO_COMPARATOR | Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216. |
| A3 and A45 Trial: Lecanemab 10 mg/kg (Extension Phase) | EXPERIMENTAL | Participants (from either A3 or A45 Trial) progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase for at least 216 weeks from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 5 mg/kg for initial 4 doses, than 10 mg/kg, administered as IV infusion, every two weeks for up to 96 weeks in extension phase. |
| Core Study: Lecanemab 10 milligram per kilogram (mg/kg) biweekly | EXPERIMENTAL | - |
| Core Study: Placebo | PLACEBO_COMPARATOR | - |
| Extension Phase: Lecanemab 10 mg/kg biweekly | EXPERIMENTAL | - |
| Extension Phase: Lecanemab Subcutaneous (SC) Injection Dose 1 | EXPERIMENTAL | This will include approximately 40 de novo participants (those that did not participate in the core study) with EAD. |
| Extension Phase: Lecanemab SC Injection Dose 2 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab SC Injection Dose 3 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab SC Injection Dose 4 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab 10 mg/kg IV Infusion Once Every 4 Weeks (Q4W) | EXPERIMENTAL | - |
| Extension Phase B | EXPERIMENTAL | Participants will receive Lecanemab 10 mg/kg IV infusion Q2W, or Q4W, or Dose 3, or Dose 4, SC injection, weekly. |
| Name | Type | Description |
|---|---|---|
| Lecanemab | DRUG | IV infusion. |
| Placebo | DRUG | IV infusion. |
| Lecanemab IV | DRUG | Administered as IV infusion. |
| Lecanemab SC | DRUG | Administered weekly as a SC injection. |
Inclusion criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known ...