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Neurology

Aducanumab

Aducanumab was the first amyloid-β-directed monoclonal antibody to receive accelerated approval from the FDA for Alzheimer disease, marking a pivotal development in disease-modifying therapy and informing the regulatory and clinical evaluation of subsequent anti-amyloid agents. Although its development was discontinued in 2024 and the medication is no longer available for new treatment initiation, its clinical experience remains relevant to understanding patient selection, amyloid confirmation,

v1 · Reviewed Nov 7, 2026 by Automated Clinical Reviewer (Strict Verbatim v1)
  • Symptoms can include, but are not limited to, headache, confusion, delirium, altered mental status, disorientation, dizziness, vision abnormalities, and nausea.
  • The historical AURs recommended excluding patients with the following characteristics: Baseline MRI evidence of hemorrhage, including cerebral microbleeds, superficial siderosis, stroke, or diffuse leukoaraiosis.
  • Current anticoagulant therapy
  • Pregnancy
  • A thorough medical history, physical examination, and neurologic examination should be conducted, incorporating a timeline of the onset and progression of cognitive decline.
  • Underlying comorbid conditions that may contribute to cognitive deterioration should be assessed with laboratory testing, including a complete blood count, comprehensive metabolic panel, thyroid function tests (TSH and free T4), lipid panel, liver function tests, and vitamin B12 concentration.
  • Brain imaging should also be performed as part of the dementia diagnostic workup to evaluate for potential neurologic conditions, such as normal pressure hydrocephalus, vascular dementia, malignancy, or subdural hematoma.
  • Amyloid confirmation through amyloid positron emission tomography (PET) or cerebrospinal fluid testing performed by clinicians experienced in lumbar puncture.
  • Brain MRI for baseline assessment and safety monitoring.
Mini-Mental State Examination (MMSE)
score of 21 to 30
Montreal Cognitive Assessment (MoCA)
score of 17 to 30
  • Clinicians experienced in recognizing prodromal and early-stage Alzheimer disease.
  • Neuroradiologists experienced in recognizing ARIA on brain MRI.
  • Clinicians knowledgeable about the recognition and management of ARIA.
  • Patient and caregiver education resources.
  • The update emphasized assessment for comorbid conditions associated with an increased risk of ARIA or its complications, including autoimmune or inflammatory disorders, seizure history, and extensive white-matter disease.
  • Clinicians prescribing currently available amyloid-targeting antibodies should counsel patients and care partners about ARIA risk and promptly assess symptoms such as headache, confusion, delirium, altered mental status, disorientation, dizziness, nausea, gait disturbance, seizures, or visual changes.
  • The former US prescribing information listed no formal contraindications; however, appropriate-use recommendations excluded patients with imaging findings or comorbidities associated with elevated ARIA risk.
  • The historical AURs recommended excluding patients with the following characteristics: Baseline MRI evidence of hemorrhage, including cerebral microbleeds, superficial siderosis, stroke, or diffuse leukoaraiosis.
  • Current anticoagulant therapy
  • Pregnancy
  • The update also recommended APOE genotyping to inform ARIA risk discussions and clinical vigilance.
  • Most ARIA events resolved without permanent discontinuation in clinical studies. The former appropriate-use recommendations advised reassessment after recurrent ARIA-E and permanent discontinuation after a third ARIA-E episode; severe ARIA warranted immediate treatment cessation and specialist care.
  • During clinical use, hypersensitivity reactions, including angioedema and urticaria, could occur during infusion. The former prescribing information directed clinicians to stop the infusion and provide appropriate management if such a reaction occurred.
  • When aducanumab was used clinically, routine monitoring for ARIA with brain MRI was required before treatment initiation and throughout therapy.
  • A brain MRI was required within 12 months before initiating aducanumab therapy.
  • The prescribing information recommended repeat MRI studies before the 5th infusion (the first 6 mg/kg dose), the 7th infusion (the first 10 mg/kg dose), and the 12th infusion (the sixth 10 mg/kg dose).
  • Additional MRI evaluation was recommended for patients who developed symptoms suggestive of ARIA-E or ARIA-H.
  • Dosing adjustments for renal or hepatic impairment were not evaluated in clinical trials.
  • Immunogenicity was uncommon; anti-aducanumab antibodies developed in approximately 0.6% of treated participants.
  • Adequate studies evaluating aducanumab use during pregnancy and lactation were not available.
  • review
    Aducanumab. StatPearls [Internet] — Inderbir S. Padda, Charles V. Preuss, Mayur Parmar — StatPearls Publishing, 2026

Decision support only. Verify against local protocols and current labeling. Source: www.ncbi.nlm.nih.gov