Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, announced that it has reached a milestone after enrolling 500 research participants in its GAIN Phase II/III trial.
The GAIN Phase II/III study is a randomised, double-blind and placebo-controlled study assessing the efficacy, safety and tolerability of two dose levels (40 and 80mg) of COR388 oral capsules in people with mild to moderate AD. The company is aiming to recruit 573 participants who will receive COR388 or placebo for 48 weeks. The primary endpoint is the mean change in the activities of daily living at week 48, measured by the Alzheimer Disease Cooperative Studies- activities of daily living (ADCS-ADL) scale.
The GAIN trial has been enrolling since the second quarter of 2019 at sites in the US and Europe. The study’s protocol includes an interim analysis, scheduled to occur after 300 participants reach 24 weeks of treatment with COR388, this is expected by the end of 2020.Top-line results from the study’s final analysis are expected in the fourth quarter of 2021.