Drug information: Aducanumab (AduhelmTM) is a monoclonal antibody that binds amyloid-β aggregates in the brain. The FDA approved aducanumab under accelerated approval based on reduction in amyloid plaques in patients treated with this medication in clinical trials. It is delivered as a monthly infusion.
Eligibility: The drug has been studied in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease. Its effects in patients without cognitive impairment or in moderate-to-severe Alzheimer’s disease are unknown.
Risks: The most common side effects are brain swelling (35%), headache (21%), microbleeds in the brain (19%) or brain lining (15%), fall (15%), diarrhea (9%), and confusion (8%). Adverse effects are more common in Alzheimer’s patients who carry the APOE ε4 (APOE4) gene.
Cost: Aduhelm is currently marketed at $28,000 a year. Additional costs associated with use of this drug include amyloid biomarker assessments (e.g., amyloid-PET), genetic testing, and serial brain MRIs to monitor safety.
Medicare and Insurance Coverage: The Centers for Medicare and Medicaid Services (CMS) issued a national coverage policy in April 2022. Medicare will cover Aduhelm only for participants in clinical trials. These trials must be approved by the FDA or the NIH.
Ongoing Clinical Trials: The Easton Center’s Kagan Clinical Trials Program is participating in EMBARK, an open-label, single-arm clinical safety study with a 2-year treatment period. This study enrolled patients with Alzheimer’s disease who had previously participated in aducanumab studies. More information will be added as it becomes available.
Clinic: Aducanumab is currently not approved on the drug formulary at UCLA Health.
For further reading see 1) Dr. Vossel’s interview about aducanumab in the UCLA Health article, What Is the New Alzheimer’s Disease Medication – and Who Should Get It? and 2) Dr. Vossel’s Op-Ed in the Los Angeles Times, “The first Alzheimer’s treatment taught us hard lessons.”