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AMSTERDAM, Netherlands: At the recent Alzheimer’s Association International Conference, researchers at pharmaceutical company Cortexyme announced an upcoming clinical trial that will target toxic substances released by the bacterium Porphyromonas gingivalis. Commonly associated with chronic periodontal disease, P. gingivalis has also been shown to have an adverse effect on Alzheimer’s disease.
The researchers provided an overview of the development of the drug, which is known as COR388, and described how they are working to test its ability to slow the progression of Alzheimer’s symptoms. They highlighted previous findings from a small early-stage clinical trial, which indicated that the drug is safe for older people. They also set out preliminary data, gathered from a 28-day study of nine people with mild to moderate Alzheimer’s disease, which showed possible indications of the drug helping to improve the participants’ memory and thinking skills, and to reduce the biological markers of the disease.
The drug’s development comes on the back of a study released earlier this year by an international team of scientists that found “strong evidence connecting P. gingivalis and Alzheimer’s pathogenesis,” according to Prof. Jan Potempa, from the University of Louisville’s Department of Oral Immunology and Infectious Diseases and co-author of the study. Potempa cautioned against jumping to conclusions, however, stating, “more research needs to be done before P. gingivalis is explicitly implicated in the causation or morbidity of Alzheimer’s”.
“Using a drug to target toxic proteins produced by the P. gingivalis bacteria has shown potential benefits in mice with features of Alzheimer’s,” said Dr Carol Routledge, Director of Research at the charity Alzheimer’s Research UK. “Now early-stage clinical trials have found the drug is safe, it’s promising to see larger trials beginning to assess whether it could improve the lives of people with Alzheimer’s.”
“While there is some evidence linking certain viruses and bacteria to Alzheimer’s disease, it is difficult for researchers to determine what role infections might play in the disease. Toxic substances released by the P. gingivalis bacteria have been found in the brains of people with Alzheimer’s, but we don’t know if this is a cause or a consequence of the disease. A clinical trial like this will help to answer this important question, while exploring a desperately needed new approach for treating the disease,” Routledge added.
At the conference in Amsterdam, which was held from 26 to 30 July, the researchers also discussed a larger study called the GAIN trial. This study is set to test the drug in 570 people with Alzheimer’s disease at approximately 90 study sites throughout the US and Europe.