II. Indications
- Alzheimer's Disease with Amyloid Beta Plaque
III. Mechanism
- Selectively bind amyloid beta Plaques in the CNS
IV. Precautions
- Aducanumab, the prototype, was FDA approved in 2021 with much controversy
- FDA over-rode its own advisory committee's vote (10 against and 1 in favor) to not approve
- Lecanemab was FDA approved via the accelerated approval pathway in 2023, with little better evidence
V. Medications
- Aducanumab (Aduhelm)
- Monoclonal Antibody infused IV every 4 weeks at a cost of $28,200 to $56,000 per year
- Infused over 45 to 60 minutes
- Start: 1 mg/kg for first 2 infusions
- Next: 3 mg/kg for next 2 infusions
- Next: 6 mg/kg for next 2 infusions
- Then: 10 mg/kg for maintenance
- Lecanemab (Leqembi)
- Monoclonal Antibody infused IV every 2 weeks at a cost of $26,500 per year
- Infusion dose: 10 mg/kg over 60 minutes
- Donanemab (Kisunla)
- Infused IV weekly over 30 minutes starting at 700 mg for the first 3 weeks, then increase to 1400 mg
VI. Efficacy
- May reduce amyloid beta Plaque, but does not appear to improve cognitive function
- No significant clinically meaningful benefit, high risk of harm, and at cost >$20,000 per year
VII. Adverse Effects
- Risk of CNS microhemorrhages and edema (NNH 13)
- Requires 3 MRIs in first 12 to 18 months of use
VIII. References
- (2023) Presc Lett 30(4): 24
- (2021) Presc Lett 28(8): 43
- Walsh (2021) BMJ 374:n1682 [PubMed]