Summary

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• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Cognitive Decline: Donanemab demonstrated a moderate slowing of clinical progression in patients with amyloid pathology, with a standardized mean difference (SMD) of -0.239 (95% CI (Confidence Interval) (0.32 points; 95% CI, 0.13 to 0.50) -0.343 to -0.134), indicating significant improvement over placebo in early-stage Alzheimer’s disease.
• Functional Decline: Donanemab reduced the risk of functional and cognitive decline by 32%, as measured by the Integrated Alzheimer's Disease Rating Scale, highlighting its impact on maintaining daily functioning in Alzheimer’s patients.
• Amyloid and Tau Levels: Donanemab effectively decreased amyloid and tau protein levels and slowed the accumulation of tau, which are key biomarkers associated with the progression of Alzheimer’s disease.
• Amyloid-Related Imaging Abnormalities (ARIA): Donanemab was associated with a significantly increased risk of ARIA-edema (RR = 10.29; NNH = 9) and ARIA-hemorrhage (RR = 1.74; NNH = 13), with symptomatic ARIA-edema observed in 24.3% of cases.
• Adverse Events: The incidence of ARIA-related adverse events, including both ARIA-edema and ARIA-hemorrhage, ranged from 26.1% to 30.5% across trials, indicating a substantial proportion of patients experienced these complications during treatment with donanemab.
• Donanemab has been primarily studied in patients with early-stage or mild-to-moderate Alzheimer's disease, with its effectiveness influenced by baseline amyloid levels, where lower amyloid levels led to complete clearance in some patients. Additionally, the presence of the APOE4 genetic allele was noted as a potential factor in patient selection, though no significant differences in effectiveness based on population types or subgroups were highlighted in the provided data.