Cassava Sciences initiates a second phase III study of simufilam for the treatment of patients with Alzheimer’s disease.
This second Phase III study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 patients with Alzheimer’s disease across clinical sites in the U.S. and Canada. Cassava Sciences’ Phase III program in Alzheimer’s is being conducted under Special Protocol Assessments (SPA) from the FDA. The SPAs document that FDA has reviewed and agreed on the key design features of each Phase III study protocol.
About The First Phase III Study (RETHINK-ALZ) : The first Phase III study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing cognitive and functional decline over 52 weeks. Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas. The company commenced patient screening for RETHINK-ALZ in October 2021, followed by patient dosing in November 2021.
About The Second Phase III Study (REFOCUS-ALZ): The second Phase III study, called REFOCUS-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.
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