Library · Brain & nerves · Early Alzheimer's disease
Lecanemab
Leqembi, lecanemab-irmb
Humanized IgG1 monoclonal antibody, accelerated FDA approval January 2023 and full approval July 2023, the first amyloid-targeting antibody fully approved for early Alzheimer’s. Targets the most neurotoxic soluble and insoluble amyloid-beta forms; its pivotal trial (1,795 participants) showed 27% slower decline over 18 months versus placebo.
Research score 90/100. Reference only, not a dose.
Boxed warning: ARIA - risk of brain swelling and bleeding. MRI monitoring required
- Amyloid Clearance
- Cognitive Protection
- US status
- Prescription Only
- Approval
- FDA Approved (Accelerated Jan 2023, Traditional July 2023)
- Evidence
- Phase 3 (1,795 patients): 27% reduction in clinical decline vs placebo over 18 months
- Research score
- 90 / 100
- Indication
- Early Alzheimer's disease (MCI or mild dementia with confirmed amyloid)
- Origin
- United States
- Source category
- Brain & Nervous System
- Status group
- Approved / prescription
Mechanism
Binds and clears soluble amyloid-beta protofibrils and insoluble plaque forms, removing the most neurotoxic species.
Safety file
Boxed warning for ARIA, requiring MRI monitoring; most common effects are headache, infusion reactions, and ARIA.
- Headache
- Infusion-related reactions
- ARIA (brain swelling/bleeding)