This segment focuses on what doctors test in the Lewy body dementia clinical trial, as well as the importance of the study participant’s care partner. Dr. Daniel Burdick, a physician’s investigator at Evergreen Hospital Medical Center in Kirkland, Washington, walks Suzanne Newman through these aspects of the clinical trial.
In the shape trial, doctors are looking at elements of safety and efficacy. Safety issues include studying bloodwork, physical exams, and checking things like changes in mood. The efficacy of the medication is studied by assessing the participant’s cognition: the person’s ability to remember, recall, fluidly use words, retain their focus and comprehension, and plan and follow events. They’ll be asked to recall words and draw figures, and these are compared from the beginning to the end of the trial. Doctors also measure brain waves with EEG to get more objective data than they can from asking questions.
By the nature of the disease, many participants in a dementia drug trial are at a point where they’re not able to assess some of their own symptoms. One of the more frustrating aspects of these diseases is that the disease itself affects the person’s ability to reflect and recognize their symptoms and limitations. One person says they can do this just fine, while it’s obvious to someone else that they really can’t. It drives the need to develop these treatments, to hopefully slow down the progression and avoid that stage.
It is a requirement of the trial — and also important for a patient’s care and safety — that they have a care partner who participates with them in the trial, someone who is a regular participant in the patient’s care. It could be a spouse, or another family member, a private caregiver, as long as it’s someone who’s with them most of the time and can observe their changes over time. And they come with them to the medical center visits.
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.
