Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lecanemab IV
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 ...
Lecanemab is an investigational drug being developed for Alzheimer's disease, including early Alzheimer's disease, preclinical Alzheimer's disease, and Alzheimer's disease generally. It is being studied in patients as young as 50 years old in clinical trials for early Alzheimer's disease.
Lecanemab targets amyloid precursor protein (APP) and acts as an inhibitor of this target. By inhibiting APP, the drug is designed to interfere with the production of amyloid beta peptides, which are implicated in the pathology of Alzheimer's disease.
Lecanemab is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the safety and efficacy of Lecanemab in patients with Alzheimer's disease.
Lecanemab is in Phase 3 clinical development for Alzheimer's disease. It has received FDA designations including Priority Review, Fast Track, and Accelerated Approval, indicating its potential importance in treating this condition, though it remains investigational.
Lecanemab is being evaluated in several clinical trials, including NCT01767311, a completed Phase 2 study in early Alzheimer's disease, and NCT03887455, an active Phase 3 study in early Alzheimer's disease. Additionally, NCT04468659 is an active Phase 3 trial in preclinical Alzheimer's disease.
Yes, Lecanemab is also known as Lecanemab IV. This alternative name refers to the intravenous formulation of the drug, which is being studied in clinical trials for the treatment of Alzheimer's disease.