Donanemab: Appropriate use recommendations - 28/03/25

Doi : 10.1016/j.tjpad.2025.100150

G.D. Rabinovici ^a,^⁎ , D.J. Selkoe ^b, S.E. Schindler ^c, P. Aisen ^d, L.G. Apostolova ^e, A. Atri ^f,^g, S.M. Greenberg ^h, S.B. Hendrix ⁱ, R.C. Petersen ^j, M. Weiner ^k, S. Salloway ^l,^{^{1
These authors contributed equally to this work.}}, J. Cummings ^m,^{^{1
These authors contributed equally to this work.}}
^a Memory & Aging Center, Departments of Neurology, Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA
^b Ann Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
^c Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA
^d Alzheimer's Treatment Research Institute, University of Southern California, San Diego, CA, USA
^e Departments of Neurology, Radiology, Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana, USA
^f Banner Sun Health Research Institute, Banner Health, Sun City, AZ, USA
^g Center for Brain/Mind Medicine, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
^h Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
ⁱ Pentara Corporation, Millcreek UT, USA
^j Department of Neurology, Mayo Clinic, Rochester, MN, USA
^k Departments of Radiology and Biomedical Imaging, Medicine, Psychiatry and Neurology, University of California San Francisco, San Francisco, CA, USA
^l Butler Hospital and Warren Alpert Medical School of Brown University, Providence RI, USA
^m Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, Kirk Kerkorian School of Medicine, University of Nevada Las Vegas, Las Vegas, NV, USA

^⁎Corresponding author at: UCSF Memory & Aging Center, 675 Nelson Rising Lane Suite 190, San Francisco, CA 94158, USA.UCSF Memory & Aging Center675 Nelson Rising Lane Suite 190San FranciscoCA94158USA

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Abstract

Donanemab (Kisunla®), an IgG1 monoclonal antibody targeting N-terminal pyroglutamate-modified forms of amyloid-β, is approved in the United States for treatment of early symptomatic Alzheimer's disease (AD). Appropriate Use Recommendations (AUR) were developed to guide the implementation of donanemab in real-world practice, prioritizing safety considerations and opportunity for effectiveness. The AUR were developed by the AD and Related Disorders Therapeutic Workgroup by consensus, integrating available data and expert opinion. Appropriate candidates for donanemab treatment include persons with mild cognitive impairment or mild dementia due to AD (Clinical Stages 3–4, MMSE 20–30) who have biomarker confirmation of AD pathology by PET or CSF. Tau PET is not required for eligibility. Apolipoprotein E (APOE) genotyping should be performed prior to treatment to inform an individual's risk of developing Amyloid-Related Imaging Abnormalities (ARIA). Pre-treatment MRI should be obtained no more than 12 months prior to treatment. Patients with findings of >4 cerebral microbleeds, cortical superficial siderosis or a major vascular contribution to cognitive impairment should be excluded from treatment. The decision to initiate therapy should be grounded in a shared decision-making process that emphasizes the patient's values and goals of care. Donanemab is administered as a monthly intravenous infusion. Surveillance MRIs to evaluate for ARIA should be performed prior to the 2nd, 3rd, 4th and 7th infusions, prior to the 12th dose in higher risk individuals, and at any time ARIA is suspected clinically. Clinicians may consider discontinuing treatment if amyloid clearance is demonstrated by amyloid PET, typically obtained 12–18 months after initiating treatment.

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Keywords : Donanemab, Appropriate use recommendations, Amyloid-targeting therapies, Antiamyloid monoclonal antibodies, Expert guidelines