Clinical neuropharmacology · 2025
Efficacy and Safety of Gantenerumab in Patients With Alzheimer Disease: A Systematic Review and Meta-analysis.
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Alla Deekshitha, Malireddi Aparna, Ramsundar Rakshna, Shah Dhruv, Alla Sai Santhosha Mrudula, Das Arghadip, Andanappa Adithya, Emmanuel Nyassiri W, Siddiqui Sofia, Marepalli Nitheesha R, Dugyala Rohit Rao, Kolte Roohi
Аннотация
BACKGROUND: Alzheimer disease is the most common cause of dementia and a major global health concern with a significant impact on elderly individuals and society. Gantenerumab, a monoclonal antibody that targets aggregated amyloid beta and removes Aβ plaques, could potentially treat Alzheimer disease.
OBJECTIVES: To systematically evaluate the safety of gantenerumab in patients with Alzheimer disease through a meta-analysis of available clinical studies.
MATERIALS AND METHODS: A comprehensive literature search was conducted, and six studies were included. Extracted data included study year, location, sample size, age, gender, gantenerumab dosage, APOE4 status, cognitive scores, CSF biomarkers, PET-SUVr, Changes in mental function, hippocampal volume, PET-SUVr, adverse effects, and mortality. Analysis was done using the R software.
RESULTS: ADAS scores increased less in the gantenerumab group than in the placebo group (MD=-1.25, 95% CI:-1.40 to -1.10, P <0.00001, I ²=88%). The increase in the FAQ score was also smaller (MD=-0.82, 95% CI: -0.92 to -0.72, P <0.00001, I ²=87%). Hippocampal volumes significantly improved (right: MD=11.93, P =0.01; left: MD=12.24, P =0.008). However, gantenerumab was linked to higher rates of ARIA-E (OR=25.62, P <0.00001) and ARIA-H (OR=1.80, P <0.00001).
CONCLUSION: In conclusion, patients with Alzheimer disease treated with gantenerumab showed significant improvement in the ADAS score, FAQ score, hippocampal volume, and CSF biomarkers compared with those treated with placebo. However, the use of gantenerumab is associated with a higher incidence of ARIA-E and ARIA-H.
OBJECTIVES: To systematically evaluate the safety of gantenerumab in patients with Alzheimer disease through a meta-analysis of available clinical studies.
MATERIALS AND METHODS: A comprehensive literature search was conducted, and six studies were included. Extracted data included study year, location, sample size, age, gender, gantenerumab dosage, APOE4 status, cognitive scores, CSF biomarkers, PET-SUVr, Changes in mental function, hippocampal volume, PET-SUVr, adverse effects, and mortality. Analysis was done using the R software.
RESULTS: ADAS scores increased less in the gantenerumab group than in the placebo group (MD=-1.25, 95% CI:-1.40 to -1.10, P <0.00001, I ²=88%). The increase in the FAQ score was also smaller (MD=-0.82, 95% CI: -0.92 to -0.72, P <0.00001, I ²=87%). Hippocampal volumes significantly improved (right: MD=11.93, P =0.01; left: MD=12.24, P =0.008). However, gantenerumab was linked to higher rates of ARIA-E (OR=25.62, P <0.00001) and ARIA-H (OR=1.80, P <0.00001).
CONCLUSION: In conclusion, patients with Alzheimer disease treated with gantenerumab showed significant improvement in the ADAS score, FAQ score, hippocampal volume, and CSF biomarkers compared with those treated with placebo. However, the use of gantenerumab is associated with a higher incidence of ARIA-E and ARIA-H.