Donanemab

For the treatment of adult patients with the following criteria:

• clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early symptomatic AD),
• heterozygous apolipoprotein-in E-ε4 (ApoE-ε4) carriers or
• ApoE-ε4 non-carriers
• confirmed amyloid pathology (amyloid PET, cerebrospinal fluid examination).

Before starting treatment, the benefits and the potential risk of serious side effects associated with ARIA must be weighed up (including pre-existing risk factors!).

Treatment only by a specialized physician qualified in the field with clinical experience in AD and prompt access to MRI examination (monitoring of undesirable side effects immediately and outside the intended examination protocol if necessary!)

MRI findings only by a specialist trained and experienced in cMRI and the specific changes!

ApoE-ε4 genotyping by a CE-marked in-vitro diagnostic device (IVD), stating the corresponding intended use! (If a CE-marked IVD is not available, an alternative, validated test procedure must be used)

For further information see technical information!

1. Sims JR, Zimmer JA, Evans CD et. al. TRAILBLAZER-ALZ 2 Investigators (2023). Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 330(6):512-527. doi: 10.1001/jama.2023.13239.
2. Zimmer JA, Ardayfio P, Wang H, et al. (2025).Amyloid-Related Imaging Abnormalities With Donanemab in Early Symptomatic Alzheimer Disease: Secondary Analysis of the TRAILBLAZER-ALZ and ALZ 2 Randomized Clinical Trials. JAMA Neurol. 82(5):461-469. doi:10.1001/jamaneurol.2025.0065
3. Zimmer JA, Sims JR, Evans CD et. al. (2025). Alzheimer's Disease Neuroimaging Initiative. Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension. J Prev Alzheimers Dis. 2025 Dec 1:100446. DOI: 10.1016/j.tjpad.2025.100446

EMA approval summary

Expert information Donanemab ^Kisunla®