Countless clinical trials are in the works around the world for measuring the effectiveness and safety of new drugs, biological treatments, devices, and diagnostic procedures. Here are four of the most exciting trials to follow in 2019.
Does Bacteria Trigger Alzheimer's Disease?
A growing body of scientific evidence suggests that the same bacteria that causes chronic periodontal disease can also infect the brain and cause Alzheimer’s Disease (AD). Consequently, the newly announced GAIN (GigipAIN Inhibitor for Treatment of Alzeheimer’s Disease) Trial will seek to determine whether the oral investigational medicine COR388 can slow or halt progression of mild to moderate AD by inactivating toxic proteins released by the pathogenic bacterium P. gingivitis.
In animal tests, these proteins have been shown to damage and destroy brains cells. Earlier tests using human subjects have detected amyloid plaques in the brains of patients with Alzheimer’s. GAIN will test the hypotheses that bacteria are an upstream trigger for AD, and that inactivating the toxic proteins they release will stop or slow down the progression of this debilitating illness, said Marwan Sabbagh, M.D., director of the Cleveland Clinic Lou Ruvo Center for Brain Health, one clinical research centers in the large Phase 2/3 clinical study of the drug from Cortexyme, Inc.
In late 2018, Cortexyme presented encouraging results from a Phase 1b clinical trial showing memory improvements in a small group of patients. A first wave of U.S. trial sites are currently screening 55- to 80-year-old patients for participation in the new GAIN study. Over coming months, GAIN expects to open more trial centers in the U.S. and Europe for enrollment.
Can a Handheld DNA Device Quickly Diagnose Infections?
Actually, the highly positive results are already in on new MiniOn DNA sequencing devices for diagnosing Huntington’s Disease, an inherited and eventually fatal disorder which stops parts of the brain from functioning properly. An expansive trial in the U.K. proved that new handheld sequencing devices from Oxford Nanopore Technologies produce much faster diagnostic answers than the traditional approach of using blood tests, which take as much as two weeks to yield results.
According to Dr. Deborah Ruddy, consultant clinical geneticist at Guy’s and St. Thomas' Hospital, the new device can reduce the stress that patients and their families undergo in awaiting test results while making treatments and support available to patients sooner. The trial produced “proof-of-principle that this new technology can be introduced into the U.K.’s National Health Service (NHS). The study was conducted by Viapath, King's College London, the South London Genomics Laboratory Hub, and the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St. Thomas’.
The U.K. clinicians are currently conducting further evaluations of the results, and that’s what’s to watch for going forward. Future goals include finding out whether this technology can also speed up diagnosis of other diseases, ranging from infections to cancers, as well as whether it can quickly identify the best treatment options based on individual DNA profiles.
Does ‘Supine MRI’ Make a Difference?
The simple but quite possibly nontrivial matter of person’s positioning during MRI exams could play a role in diagnostic accuracy. That’s the idea behind a new clinical trial at Dana-Farber Cancer Institute in Boston. Researchers there are investigating the value of supine MRI in treating women with breast cancer before and after the women receive neoadjuvant therapy designed to reduce the extent of cancer prior to other treatments.
Typically, women experiencing neoadjuvant therapy have received standard MRIs, lying on their stomachs. Supine MRI, on the other hand, is performed while patients are lying on their backs, according to the U.S. National Library of Medicine's ClinicalTrials.com website.
The researchers at Dana-Farber theorize that the use of supine breast MRI could help doctors to view the size and location of tumors more precisely. Other procedures involved in the trial include mammography and ultrasound. First launched in November, 2016, the trial is currently slated for completion in December, 2021.
Can a Human Antibody Thwart Gastric Cancer?
Different types of cancer strike at different rates in various parts of the world. Although gastric cancer has been declining in most nations, it’s on the rise in China. There, it’s the second leading cause of cancer-related deaths after lung cancer, according to data from the Chinese National Cancer Center.
In response, a clinical trial is now up and running in China of a treatment for gastric cancer which combines chemotherapy with CS1001, China’s first fully human, full-length anti-PD-L1 antibody. In April of 2019, CStone Pharmaceuticals announced that the first patient had been successfully enrolled and dosed in a Phase III clinical trial of the new treatment.
Previously, most gastric cancer patients had been treated with chemotherapy alone. The only available biologic drug therapy was restricted to HER2-positive cases, which account for only a small percentage of total patient numbers in China. Hopefully, CS1001 will help to curtail the devastating disease of gastric cancer.
Have Plans for a Clinical Trial?
Whether it's a single local study or a multi-site global trial, of course, clinical trial equipment is required. Many clinicians find it much more economical to lease than buy. Fortunately, there are companies like Axelerist, which offer no-hassle leasing for any clinical trial equipment you need, including ECCs, centrifuges, incubators, refrigerators, and freezers from many top manufacturers.
Clinicians around the globe are hard at work on trials for better diagnosis and treatment of infections, cancer, Alzheimer's, and endless other human maladies. Who knows what clinical trials will show us next?