When you pass the nondescript sign on Cortez Boulevard for Meridien Research you may wonder what goes on there. Well, there is an interesting answer to that question. Meridien Research is currently one of 90 medical research facilities nationwide that will be conducting a study on a pharmaceutical drug called AC1204 that treats alzheimer's disease in a way unlike traditional medications.
Established in 2000, Meridien Research has five privately owned clinical locations throughout the Tampa Bay area. At the Brooksville location those with conditions including arthritis, cognitive impairment, diabetes type I and II, cardiovascular, eczema and fibromyalgia can enroll in medical studies with those ailments.
Currently Alzheimer's medications treat the disease through regulation of neurotransmitters in the brain. One option regulates cholinesterase for mild to moderate Alzheimer's and another type of medication regulates glutamate for more advanced Alzheimer's. In contrast to brain chemical regulation, AC1204 works by changing how the brain is nourished. Glucose is the main energy source for our brain, however there is another energy source, called ketones, that the brain can use to function. This is important because those with Alzheimer's disease cannot utilize glucose in the brain efficiently. AC1204 helps the brain to process these ketone bodies instead of glucose for energy.
When your brain is using ketones instead of glucose metabolism, the process is referred to as ketosis. Ketosis can be established through a highly regulated diet that is rich in healthy fats or medium chain triglycerides such as those found in coconut oil. The diet must also be very low carb and low protein.
However such a diet is extremely difficult to adhere to, especially for someone with cognitive impairment. As an alternative to the strict diet, ketone ester supplementation was examined in a 2015 single case study featured in Alzheimers & Dementia, the Journal of the Alzheimer's Association. The study showed higher blood plasma levels of ketones with the supplementation of the ketone ester. The patient showed markedly improved cognition with higher levels of ketones in the blood while taking the supplement.
The current trial which Dr. Kelli Maw of Meridien Research is conducting, is a 6 month efficacy of AC1204. Accera, the manufacturer of AC1204, intends to enroll 480 patients with Alzheimer's Disease nationwide into the randomized, double blind, placebo controlled study. Meridien Research is searching for 8 individuals to participate in their portion of the study, but in order to find that number, they must screen many more.
They are looking for individuals with Alzheimer's disease between the ages of 56 and 90 years old who have a study partner to assist them with appointments, medication and monitoring their condition. There are other factors considered such as overall health. Participants will not be required to alter their diet and can continue to take regularly prescribed Alzheimer's medications. Dr. Maw stated that the drug generally has very few side effects.
The primary investigation will compare the effects of a daily dose of AC1204 to the placebo in Alzheimer's patients. During the study period, patients will be expected to come back to the clinic five times for neurocognitive and physical exams.
Following the 6 month study, participating patients have the option of taking the investigational drug AC1204 for an additional 6 months. During the second 6 months, patients would be required to make two visits to the clinic and correspond with the clinic through four phone calls.
To find out more about participating in this study, call Meridien Research at (352) 597- 8839.