This segment focuses on what it means to be involved in the Lewy body dementia shape trial. Dr. Daniel Burdick, a physician’s investigator at Evergreen Hospital Medical Center in Kirkland, Washington walks Suzanne Newman through the process.
Participating in a clinical trial is a donation of time to the global effort to develop better treatments for Parkinson’s disease and Dementia with Lewy Bodies. It can be involved. This particular trial is a 6-8 month process with 9 or 10 visits to the Kirkland site, one every 4-6 weeks, each one a couple to several hours each, with doctors spending lots of time with them. Doctors ask detailed questions and get to know their experiences in much greater detail, and people have said that it’s a positive experience because they feel really connected. A research coordinator becomes their navigator through the trial.
The purpose of the trial is to gather a group of people together and compare changes among three different groups, to see whether a high dose medication was more effective than the low dose medication, and whether a low dose medication was more effective than a placebo, a sugar injection. The trial measures safety and efficacy in multiple ways, with questionnaires and even with an EEG that measures brain waves, using a cap with electrodes. You have a 1 in 3 chance of being in one of the groups. Neither you nor your physician knows which group you’re in, and neither does your physician coordinator, so it’s “blinded,” which is essential to analyzing the results. There’s an open label extension afterwards, where after the 6-8 month period, you have the option of continuing into a phase of the trial where you know you’re getting the actual drug.
The shape trial studies a specific treatment for Lewy body dementia. It’s being studied in Florida, Georgia, Michigan, Oregon, Pennsylvania and Washington, To learn more and sign up for this trial, go to https://shapetrial.com/. If you’re in the Seattle area, you can also sign up at Evergreen Hospital Medical Center in Kirkland. Courtesy of Athira Pharma.
