GAIN Study
Study Sponsor: Cortexyme

The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is based on a growing body of scientific evidence that the bacteria P. gingivalis, most commonly associated with degenerative gum disease, can infect the brain and cause Alzheimer’s disease. 

This clinical trial will evaluate whether the investigational oral drug COR388 is safe and can slow or halt the progression of Alzheimer’s disease by inactivating the toxic proteins, called gingipains, released by the bacteria and stop or slow further damage to healthy brain cells.  

The GAIN Trial is looking to enrol more than 500 participants with mild to moderate Alzheimer’s disease at more than 90 clinical trial centres in the United States and Europe. 

Clinical Trials Are the Path to New Treatments

With a lack of effective long-term treatments, researchers are working hard to find new and better approaches for slowing the progression of Alzheimer’s disease. Advances in treatment are only possible through clinical research and trials like GAIN. A clinical trial is a medical research study to explore whether an investigational drug is safe and effective for humans. These trials follow strict scientific standards and regulatory requirements to protect patients and help produce reliable results.

A clinical trial may find that a new intervention improves patient outcomes, offers no benefit or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care. Study physicians will review risks and potential benefits with patients and their caregivers before patients are enrolled in the GAIN Trial. All new drug candidates like COR388 are studied in clinical trials to generate data that can be evaluated by the US Food and Drug Administration (FDA) and other regulators for safety and effectiveness before being approved for common use.

The GAIN Trial is recruiting more than 500 participants with Alzheimer’s disease at more than 90 clinical trial centres in the United States and Europe.

Subjects enrolled in the study will be randomly assigned to one of three groups:

  • One-third will take an 80 milligramme pill of the study drug COR388 by mouth twice a day
  • One-third will take a 40 milligramme pill of COR388 by mouth twice a day
  • One-third will take a placebo (sugar pill) by mouth twice a day 

In order to scientifically assess the effects of the drug, neither the participants nor the clinical team will know during the study what group each patient is in. Participation in the study will last about one year. All eligible participants who complete the one-year study may have the opportunity to enrol in a follow-on study in which all subjects receive COR388. 

Gain is Not Actively Enrolling Subjects at This Time

Scientific experts have discovered that a bacteria called P. gingivalis, most commonly associated with degenerative gum disease, can infect the brain in older people who are more susceptible.  Once in the brain the bacteria releases toxic proteins, called gingipains, that have been shown to destroy neurons and cause other signature signs of Alzheimer’s disease in the brain in physiological animal models. COR388 is designed to inactivate the toxic gingipains created by the P. gingivalis bacteria, reduce inflammation, reduce the bacterial infection and slow or halt progression of Alzheimer’s disease.

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COR388 is being developed by Cortexyme, Inc.

Gain is Not Actively Enrolling Subjects at This Time