The University of West Florida is now conducting its first-ever clinical trial as part of a nationwide research study on Alzheimer’s disease.
“The TRIAD Study is designed around an investigational new drug to help alleviate the symptoms of agitation associated with Alzheimer’s disease,” said Dr. Rodney Guttmann, UWF biology professor and clinical trials principal investigator.
The research team also includes Kristina Robison, clinical trials manager and Assistant Vice President of Research Dr. Mark Roltsch.
“We’re excited to bring the study to Pensacola because this is the first study that UWF has done as a clinical trial,” Dr. Guttmann said of the opportunity to conduct human testing of a drug that possibly could benefit those suffering from Alzheimer’s disease. “But, also from the perspective, as an Alzheimer’s researcher for a number of years, it’s nice to now be able to take things from bench to bedside.”
This particular study focuses on agitation, which affects almost 4.3 million of the 5.4 million people with Alzheimer’s disease.
While there’s no current treatment or cure for Alzheimer’s, Dr. Guttmann says some of the behaviors associated with the disease can be addressed and agitation is one of the more significant ones.
“It results in a lot of caregiver stress, for example, and it’s bad for the patient as well," said Guttmann. "So, looking for drugs that can treat some of these behaviors, particularly agitation, I think will be very important in the overall scheme of managing Alzheimer’s for our community.”
The TRIAD Research Study is a phase 3 trial, which means that there have already been studies assessing the safety and efficacy of the drug.
The clinical trial at UWF is being conducted in partnership with Dr. John Hayes. Hayes is medical director at the West Florida Memory Disorder Clinic and serves as medical investigator for the clinical trial.
For the 12-week study period, patients and their caregivers have to commit to eight visits to the study site on the UWF main campus.
The appointments, ranging in length from a few minutes to a few hours, will involve some memory testing and some other assessments associated with Alzheimer’s disease.
During the study, participants will take a medication twice a day. However, as is typical with clinical trials involving drugs, some will get the actual medication and some will not.
“This is what we call a double-blind, placebo-controlled trial,” said Dr. Guttmann, noting that this type of study is considered to be the gold standard in clinical trials. “Double-blind means that neither I nor the patient knows whether or not they’re getting the active drug or not. And, the placebo control is they may or may not be getting the active drug. In our particular study, there’s a 40% chance of placebo and 60% chance of receiving active drug.”
UWF is now seeking up to 25 participants for the local study site, which is one of about 70 sites involving up to 450 individuals nationwide.
Eligible patients need to have an Alzheimer’s disease diagnosis, experience agitation due to the disease, and be between the ages of 50 and 90 years old.
There are other more specific inclusion and exclusion criteria. Also, a review of medical records will be conducted to make sure patients don’t have other issues that might exclude them from the study.
Guttmann says individuals who qualify will be able to come into the trial at different times over the two-year study period, which runs through the end of 2019.
After the clinical trial is over, participants who complete the 12 weeks will be able to continue as part of an extension study.
“If we didn’t have the extension study, then it would be over,” said Guttmann, adding that access to the drug and any benefit from it would be over too, since this is an investigational drug.
In this case, though, everyone that finishes the clinical trial will be eligible to enroll in a yearlong study where they would get the study medication for an additional year. For the extension study, all would get the actual medication; there would be no placebo.
What UWF researchers need now is willing participants for the current TRIAD Research Study.
For those who may be thinking about it, Dr. Guttmann suggests taking a moment to consider the importance of clinical trials and completing them sooner, rather than later.
“Scientists need participants, and the only way that new drugs come to market is by going through the clinical trial process,” Guttmann said.