Phase 3 Trials of Gantenerumab Likely to Decide Clinical Benefit, Roche Says in Interview

Phase 3 Trials of Gantenerumab Likely to Decide Clinical Benefit, Roche Says in Interview
Roche soon will start two Phase 3 trials testing gantenerumab, its amyloid-targeting treatment candidate, in prodromal, or early, Alzheimer’s patients. Each plans to enroll 750 people, ages 50 to 90, and will judge gantenerumab’s effectiveness and potential clinical benefit by looking at changes in dementia and amyloid plaque load in the brain. The Phase 3 trials — GRADUATE1 (NCT03444870) and GRADUATE2 (NCT03443973) — will run for two years and be conducted at sites across the U.S, Canada, Europe, South America, Australia, and Asia. “We haven't published an exact date, but we're definitely about to start these studies soon,” Rachelle Doody, MD, Roche’s global head of Neurodegeneration, said in an interview with Alzheimer’s News Today. Patients will receive monthly, subcutaneous (under the skin) doses of gantenerumab, which will be titrated, or gradually increased, every three months. “The most important thing to realize about this titration is that it's the same for all patients, regardless of their APOE genotype,” Doody said. The combination of the two APOE gene copies determines the APOE genotype, a well-known risk factor for Alzheimer’s. The studies will be highly similar — same treatment, dosing, and outcome measures — to comply with US. Food and Drug Administration requirements that study results be replicated to ens
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