This segment focuses on misconceptions of clinical trials and who qualifies for the Lewy body dementia clinical trial. Dr. Daniel Burdick, a physician’s investigator at Evergreen Hospital Medical Center in Kirkland, Washington, covers these topics with Suzanne Newman.
Regarding misconceptions, Dr. Burdick says he’s often asked about placebos. He explains that people have an expectation that the the reason to go into a clinical trial is because it will benefit them. And of course they hope it will, but they don’t know that it will for sure. When people hear there’s a chance of getting a placebo, they think maybe it’s not worth participating in the trial. That’s a misconception, because the only way we can know if a treatment is safe and effective is by comparing a group of patients who take it with a group of patients who don’t. Even if a person participates in a trial and gets the placebo for the double blind period, they are still contributing to something that will make their own future better.
Another misconception is their stage of progression. Some people feel they’d go into a clinical trial only if there’s no other chance, no other hope. That might have been the case in oncology trials in some other era, but it’s not the case in neurology trials, and not for the shape trial and other trials in Parkinson’s dementia and Dementia with Lewy Bodies. They’re looking for people who meet the eligibility requirements, but who have maybe not advanced that far in the disease, at a moderate stage of the disease. Some trials for Parkinson’s are looking for people in early stages of the disease. Regardless of your stage in a disease, you can find a clinical trial to participate in.
Some people may wonder if a drug in a drug trial is safe. By the time a drug is being tested in patients with the target disease, which is called a phase-2 trial, it has already gone through initial safety trials with animals and a phase 1 trial in healthy people who have volunteered to make sure the drug is safe.
Who is eligible to participate in the shape trial? Candidates are 40-85 years old and have been diagnosed with Parkinson’s disease dementia or Dementia with Lewy Bodies. There are other criteria. There’s no cost to participate, and actually you get a small stipend for each visit.
Many patients being assessed at the Evergreen site have a primary care doctor outside of the Evergreen system, and they communicate with the primary care physician, ask for medical records as part of the screening process, and if any medical concerns come up, they communicate very closely with the primary care doctor for followup.
Participating in a clinical trial is the best quality of care anybody can have, because of the intense attention, you’re much more involved, monitored more closely, you’re far more equipped to recognize progression of the illness than an average person would notice.
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.
