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Donanemab: Appropriate use recommendations
G D Rabinovici1, D J Selkoe2, S E Schindler3
1Memory & Aging Center, Departments of Neurology, Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.
The Journal of Prevention of Alzheimer'S Disease
|March 28, 2025
Summary
Donanemab is approved for early Alzheimer's disease (AD). These recommendations guide its safe and effective use in clinical practice, focusing on patient selection and monitoring for side effects like ARIA.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Donanemab is an approved IgG1 monoclonal antibody for early symptomatic Alzheimer's disease (AD).
- Appropriate Use Recommendations (AUR) are crucial for guiding donanemab's real-world implementation.
- Prioritizing safety and effectiveness is key for patient management.
Purpose of the Study:
- To establish guidelines for the appropriate use of donanemab in clinical practice.
- To define patient eligibility criteria and safety monitoring protocols for donanemab therapy.
- To integrate expert opinion and available data for optimal donanemab administration.
Main Methods:
- Development of AUR by the AD and Related Disorders Therapeutic Workgroup through consensus.
- Integration of current data and expert clinical judgment.
- Definition of patient profiles, including biomarker confirmation and exclusion criteria.
Main Results:
- Appropriate candidates: Mild cognitive impairment or mild dementia due to AD (Clinical Stages 3-4, MMSE 20-30) with confirmed AD pathology (PET or CSF).
- Safety considerations: APOE genotyping recommended; MRI pre-treatment required; exclusion criteria include specific vascular findings and microbleeds.
- Monitoring: Surveillance MRIs for ARIA before specific infusions and as clinically indicated; potential treatment discontinuation upon amyloid clearance.
Conclusions:
- Donanemab AUR provide a framework for safe and effective treatment of early symptomatic AD.
- Shared decision-making is essential, considering patient values and goals of care.
- Careful patient selection, monitoring for ARIA, and consideration of amyloid clearance guide long-term management.
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