Aducanumab: Appropriate Use Recommendations.
J Cummings1, P Aisen, L G Apostolova
1Jeffrey Cummings, MD, ScD, 1380 Opal Valley Street, Henderson, NV 89052, jcummings@cnsinnovations.com, T: 702-902-3939.
The Journal of Prevention of Alzheimer'S Disease
|September 29, 2021
Summary
Aducanumab, an amyloid-targeting therapy for Alzheimer's disease (AD), should be used in early AD patients with confirmed brain amyloid. Recommendations focus on maximizing dose, monitoring for ARIA, and patient-centered decision-making.
Area of Science:
- Neurology
- Pharmacology
- Biotechnology
Background:
- Aducanumab is an FDA-approved amyloid-targeting monoclonal antibody for Alzheimer's disease (AD).
- Clinicians need guidance for appropriate use of this novel AD therapy.
- An Expert Panel convened to establish Appropriate Use Recommendations.
Purpose of the Study:
- To provide guidance on the appropriate use of aducanumab for Alzheimer's disease.
- To define the patient population and treatment parameters for aducanumab therapy.
- To outline safety monitoring and informed decision-making processes for aducanumab.
Main Methods:
- Recommendations based on pivotal trial data, Prescribing Information, and expert consensus.
- Defined target population: early AD with confirmed brain amyloid.
- Established dosing titration, ARIA management, and MRI monitoring protocols.
Main Results:
- Recommends aducanumab use restricted to early AD patients with confirmed amyloid.
- Suggests titration to the highest dose (10 mg/kg) over 6 months for maximal efficacy.
- Outlines management of amyloid-related imaging abnormalities (ARIA), including MRI monitoring and dose adjustments.
Conclusions:
- Aducanumab use should be limited to the studied population (early AD with amyloid confirmation).
- Titration to the maximum dose is recommended, with careful monitoring for ARIA.
- Patient-centered informed decision-making is crucial, addressing therapy requirements, outcomes, risks, and uncertainties.
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