ينطبق هذا البروتوكول على المرضى المشخصين بمرض ألزهايمر المبكر الذين لديهم أمراض الأميلويد الدماغي مؤكدة ببيوماركرات السائل النخاعي أو PET الأميلويد، والذين يعانون من ضعف إدراكي بدرجة خفيفة على الأقل إلى جانب ضعف معدوم إلى خفيف في أنشطة الحياة اليومية.
DOI: 10.1016/S0140-6736(25)01329-7
Trial requirements, mirrored by market labels, included a diagnosis of cognitive impairment with no to mild activities of daily living impairment and evidence of cerebral amyloid pathology based on CSF biomarkers or amyloid-PET.
Therefore, patients with cognitive impairment due to alternative clinical diagnoses or more advanced Alzheimer's disease with moderate to severe ADL impairment should be excluded.
In the EU, the UK, and Australia, patients who are homozygous for APOE ε4 are not eligible for anti-β amyloid monoclonal antibodies due to the higher ARIA incidence.
Donanemab intravenously every 4 weeks; lecanemab intravenously every 2 weeks; and subcutaneous formulations under development.
The clinical trials of donanemab and lecanemab allowed co-treatment with cholinesterase inhibitors, memantine, or both.
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