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This secondary analysis of the TRAILBLAZER-ALZ 2 trial examined whether lower amyloid plaque levels after treatment were associated with slower clinical progression in early symptomatic Alzheimer disease. The analysis included 1,582 participants: 766 treated with donanemab and 816 receiving placebo. Lower post-treatment amyloid levels were strongly correlated with slower clinical worsening, measured using the integrated Alzheimer’s Disease Rating Scale (iADRS; \(R^2=0.73\); 95% CI, 0.37–0.97) and Clinical Dementia Rating–Sum of Boxes (CDR-SB; \(R^2=0.87\); 95% CI, 0.70–0.97). Lower amyloid levels were also correlated with reductions in plasma phosphorylated tau and glial fibrillary acidic protein, but not neurofilament light chain. These findings support a relationship between amyloid clearance and clinical outcomes. However, because this was a secondary, exploratory analysis, the correlations do not independently establish amyloid levels as a validated surrogate endpoint for clinical benefit.
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This secondary analysis of the TRAILBLAZER-ALZ 2 trial examined whether lower amyloid plaque levels after treatment were associated with slower clinical progression in early symptomatic Alzheimer disease. The analysis included 1,582 participants: 766 treated with donanemab and 816 receiving placebo. Lower post-treatment amyloid levels were strongly correlated with slower clinical worsening, measured using the integrated Alzheimer’s Disease Rating Scale (iADRS; \(R^2=0.73\); 95% CI, 0.37–0.97) and Clinical Dementia Rating–Sum of Boxes (CDR-SB; \(R^2=0.87\); 95% CI, 0.70–0.97). Lower amyloid levels were also correlated with reductions in plasma phosphorylated tau and glial fibrillary acidic protein, but not neurofilament light chain. These findings support a relationship between amyloid clearance and clinical outcomes. However, because this was a secondary, exploratory analysis, the correlations do not independently establish amyloid levels as a validated surrogate endpoint for clinical benefit.
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