Cassava Sciences, Inc. announced the completion of patient dosing in a 6-month, randomized controlled trial of simufilam in over 125 patients with Alzheimer's disease. This trial is known as the Cognition Maintenance Study (CMS). Simufilam is Cassava Sciences' investigational oral drug treatment for Alzheimer's disease dementia.

The CMS is a randomized, double-blind, placebo-controlled, 6-month trial designed to evaluate the safety and efficacy of simufilam in patients with mild-to-moderate Alzheimer's disease dementia. The CMS follows a randomized withdrawal study design. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam.

Enrollment in the CMS was open to all patients who responded to open-label treatment, as well as to all patients who had no apparent response to open-label treatment. CMS study participants were randomized (1:1) to simufilam or placebo. The primary outcome measures are safety and change in cognition scores (ADAS-Cog) over 6 months in over 125 patients who completed dosing.

The CMS dataset remains locked and blinded. After unlocking, the dataset will be analyzed by outside biostatisticians. Subgroup analyses may include patients by stage of disease, prior response to open-label treatment, baseline scores or other crucial shared characteristics.