SPRINGFIELD, NJ — Dr. Michelle Papka isn’t looking to cure Alzheimer’s disease tomorrow.
Papka, the principal investigator for a new study for Alzheimer’s at the Cognitive and Research Center in Springfield, is hoping a new approach she is taking will be a step in the right direction.
“It is important to explore all approaches,” Papka said Aug. 14. “This study is different than most we’ve done in the past one or two years, and it is also the first time in a few years that the testing of an Alzheimer’s drug has made it this far.”
The study, known as the GAIN trial, is based on a growing body of scientific evidence that the P. gingivalis bacteria — most commonly associated with gum disease — can infect the brain and cause Alzheimer’s disease. The study is testing whether COR388, an oral medication taken twice per day, can slow or halt the progression of Alzheimer’s by inactivating the toxic proteins released by P. gingivalis, which have been shown in animal studies to damage and destroy brain cells. It is being funded by Cortexyme, the California-based pharmaceutical company that developed the medication.
“This study has shown some positive early results,” Nancy Wellbrock of Alzheimer’s New Jersey, said in a recent email to LocalSource. “We look forward to seeing additional results in the future.”
The Cognitive and Research Center of New Jersey is a private medical practice that treats patients with Alzheimer’s disease, in addition to performing research. The center, which has a second office in Raritan, is currently looking to enroll subjects as part of the study. It will include more than 500 people between 55 and 80 years old who have a documented diagnosis of mild to moderate Alzheimer’s disease.
The center runs “clinical trials focused on memory loss, Alzheimer’s disease, mild cognitive impairment, and dementia,” according to its website. “We provide opportunities to receive experimental treatments and related resources that are unavailable anywhere else. Our goal is to advance the state of research and treatment for these diseases, find the most effective new treatments, and eventually contribute to eliminating them altogether.”
CRCNJ is one of more than 90 locations in the United States and Europe being used for clinical trials of the study drug COR388, according to Cortexyme. Randomized participants enter a screening period of up to six weeks, a 48-week treatment period, and a safety follow-up period of an additional six weeks, according to Cortexyme’s website.
“The bacteria does its damage by placing itself inside brain cells,” Cortexyme Chief Medical Officer Dr. Mike Detke said via email through CRCNJ’s publicist. “Once the bacteria is inside of the cells, they begin to collapse and die.”
The company thinks COR388 may be able to slow or halt the damage this bacteria does to brain cells, which could also lead to the slowing of Alzheimer’s disease.
Alzheimer’s is an irreversible brain disease that slowly destroys cognitive skills and eventually the ability to carry out daily activities. “Dementia” is a term for a group of brain disorders that cause problems with thinking, memory and behavior. Alzheimer’s disease is the most common type of dementia, affecting more than 5.8 million people in the United States alone, according to the Texas Department of State Health Services. Of this number, 5.6 million are age 65 and older.
The GAIN trial, if successful, would advance COR388 to be approved by the U.S. Food and Drug Administration, and help take a big step in finding better treatment for Alzheimer’s disease, Papka said.