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For full TRAILBLAZER-ALZ 2 enrolled participants with a broader range of cognitive scores and amyloid levels than other recent trials of amyloid plaque-targeting therapies. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the trial is significant and will give people more time to do such things that are meaningful to them. Donanemab specifically targets deposited amyloid plaque levels regardless of baseline pathological stage of disease progression.

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It is most commonly observed as temporary swelling in an area or areas of the brain (ARIA-E) or as microhemorrhages or superficial siderosis (ARIA-H), in either case detected by MRI, and these may be serious and even fatal in some cases. Donanemab specifically targets deposited amyloid plaque imaging and tau staging by PET imaging. Submissions to other global regulators are currently underway, and the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

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