GingipAIN Inhibitor for Treatment of Alzheimer’s Disease (GAIN) Trial is based on a body of scientific evidence that P. gingivalis, bacteria which is most associated with degenerative gum disease, can also affect the brain and possibly lead to Alzheimer’s disease.
This clinical trial determines whether the experimental oral drug Atuzaginstat is 1. safe and 2. Is able to retard or stop the development of Alzheimer’s disease. The drug is intended to accomplish this by inactivating specific toxic proteins, called gingipains, which are released by the bacteria to stop or slow down further damage to healthy brain cells.
How the study was organized
Subjects enrolled in the GAIN Trial study are randomly assigned to one of the following three groups:
- One-third would be given an 80 mg pill of the study drug Atuzaginstat by mouth twice a day
- One-third would be given a lower dose of a 40 mg pill of Atuzaginstat by mouth twice a day
- One-third would be given a placebo sugar pill by mouth twice a day
To accurately assess the effects of the drug, neither the participants nor the clinical team are aware, during the study, which group each patient belonged in. Further, participation in the study lasts about one year.
All eligible American participants who finish the 12-month program may be given an opportunity to participate in follow-on research in which all subjects receive Atuzaginstat.
Researchers discovered that P. gingivalis bacteria, most associated with degenerative gum disease and gingivitis, can spread to the brains of older people who are more susceptible. Once in the brain, the bacteria release toxic proteins, called gingipains, that have been shown to destroy neurons and cause other signature signs of Alzheimer’s disease in the brains of animals. Atuzaginstat was designed and manufactured to deactivate the toxic gingipains created by the P. gingivalis bacteria, reduce any bacterial infection, and slow or stop the growth of Alzheimer’s disease.
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