Cortexyme, Inc. has reportedly launched the GAIN Trial, a worldwide Phase 2/3 clinical trial of COR388, the company’s lead investigational drug, in patients suffering from mild to moderate Alzheimer’s disease. The first wave of trial sites in the U.S. are now examining patients for participation, and more trial centers in the US and Europe are projected to be open for enrollment in the near future, reported sources.

According to a press release by Cortexyme, the GAIN Trial is based upon a growing body of scientific proof that Porphyromonas gingivalis, a pathogenic bacterium that’s commonly linked to chronic periodontal disease, can contaminate the brain and lead to Alzheimer’s disease. The clinical trial is assessing the oral investigational medicine COR388’s ability to slow or pause the progression of Alzheimer’s disease by deactivating the gingipains or toxic proteins released by P. gingivalis, which have been proven to damage and destroy brain cells in animal prototypes.

GAIN is a randomized, placebo-controlled, double-blind Phase 2/3 clinical trial with an objective to enroll over 570 participants at more than 90 sites across Europe and the United States. Partakers need to be 55 to 80 years old and possess a documented diagnosis of mild to moderate Alzheimer’s, among other requirements. Subjects will be randomized to one of two COR388 dosages or placebo. The primary endpoint for the trial is mean change in ADAS-Cog 11 from zero to 48 weeks. The secondary and experimental endpoints involve changes in Clinical Dementia Rating-Sum of Boxes, Alzheimer’s Disease Cooperative Study Group-Activities of Daily Living, cerebral spinal fluid biomarkers of infection, Winterlight Speech Assessment, and other measures, cited sources familiar with the trial.

For the record, COR388 is a high-quality drug that targets P. gingivalis gingipains. According to a paper available with Science Advances, a group of researchers, including Dr. Stephen Dominy, M.D., Chief Scientific Officer of Cortexyme, provided complete preclinical data about COR388’s capability to block production of amyloid beta, decrease the bacterial load of a P. gingivalis infection, lessen neuroinflammation, and shield neurons in the hippocampus, reported sources.