Cassava Sciences reports results of two-year study of simufilam

Cassava Sciences reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer’s disease dementia. The study enrolled over 200 patients with mild to moderate Alzheimer’s and consisted of two open-label treatment phases and a randomized, placebo-controlled withdrawal phase. Average changes in ADAS-Cog scores, baseline to month 24, indicate the following: Patients with mild Alzheimer’s disease who received simufilam treatment continuously for two years had no decline in ADAS-Cog scores as a group. Patients with mild Alzheimer’s who received simufilam treatment non-continuously declined 1 point on ADAS-Cog as a group. Non-continuous treatment consisted of one year on open-label drug, six months on placebo and six months back on open-label drug. In patients with mild Alzheimer’s, the largest separation between the continuous and non-continuous treatment groups occurred at the end of the 6-month randomized, placebo-controlled withdrawal phase. Patients with moderate Alzheimer’s who received simufilam treatment continuously for two years declined 11.05 points on ADAS-Cog as a group. This was a 24-month safety study. The safety study was conducted in three continuous phases: a 12-month, open-label treatment phase, followed by a 6-month randomized, placebo-controlled withdrawal phase1, followed by 6 additional months of open-label treatment.