Roche Set to Start Two Phase 3 Trials of Gantenerumab in People with Early to Mild Alzheimer’s

Roche Set to Start Two Phase 3 Trials of Gantenerumab in People with Early to Mild Alzheimer’s
The safety and efficacy of Roche’s gantenerumab, a treatment candidate for Alzheimer’s, will be tested in two global Phase 3 clinical trials in patients with early to mild forms of the disease. The studies follow a long research process that defined the therapy's optimal dose. The GRADUATE1 (NCT03444870) and GRADUATE2 (NCT03443973) trials will both run for two years (104 weeks) and are set to start in July 2018. They will measure treatment effectiveness against placebo by looking changes in dementia severity at the trials' end. The company plans to enroll 750 patients, ages 50-90, in each trial at sites across the U.S, Europe, South America, Australia and Asia. Both will transition into open-label extension studies. Patients not wishing to continue in them will be followed for up to 50 weeks after the last gantenerumab dose. Gantenerumab is a fully human antibody that targets beta-amyloid, a protein that accumulates in neurons and is the main component of amyloid plaques found in the brains of Alzheimer’s patients. Potential benefits of treatment — given as under-the-skin injections — will be compared with placebo. Both studies will analyze effectiveness using the Clinical Dementia Rating Sum of Boxes (CDR-SB) scores, a global assessment tool that determines dementia severity. Scientists will also assess gantenerumab’s effects using other Alzheimer’s-related scale
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