LBDA’s Research Centers of Excellence (RCOE) program presented a virtual symposium on “biomarkers” on January 25, 2021. A biomarker is a biological sign that reveals the presence or severity of a disease. For example, a biomarker of diabetes is “hemoglobin A1C”, which averages a person’s blood sugar levels over time, and suggests how well a person’s diabetes is being controlled.
Using Biomarkers in Research
Biomarkers are very important for the development of new treatments. A biomarker can be used to improve diagnostic certainty, which helps select the right participants for clinical trials. A biomarker can also serve as a “surrogate marker” of disease activity or severity. These can be used to show differences in outcomes between two groups of study participants: the group receiving the active drug compared to those receiving a placebo.
Biomarkers can be particularly important in diseases like Lewy body dementia (LBD), where diagnosis is challenging, or clinical outcomes vary. Researchers in LBDA’s RCOE program are very interested in identifying and validating biomarkers for use in LBD clinical trials. (A validated biomarker means that the results have been independently reproduced in a separate study, confirming the reliability of the test.)
About the Symposium
As the pandemic forced the cancellation of many scientific meetings, opportunities to present new advances in LBD biomarkers have been limited. So LBDA organized a virtual event featuring eight internationally known scientists from Europe and the US. The event attracted over 200 scientists and physicians from academic centers, the National Institute of Health and the pharmaceutical industry.
Diagnostic Biomarker Progress
One of the most important goals for LBD research is to identify a biomarker to serve as a diagnostic test for Lewy bodies in the brain. The speakers described promising efforts from spinal fluid tests, skin biopsies, and other biopsies. The symposium also reviewed the reliability of these tests for diagnosis, and the potential to use some of these tests as markers of disease progression or severity. One of these tests is now commercially available for Parkinson’s disease, and another one will be offered starting in 2021.
Also of importance, many people with LBD also have brain changes related to Alzheimer’s disease; these changes are the presence of “plaques” and “tangles”. Biomarker research in this area has also advanced rapidly in the past year. Blood tests for these types of brain changes have been validated and will also be commercially available soon, likely in the next calendar year.
These two advances will help LBD researchers to confirm that clinical trial participants have Lewy bodies in the brain and will also determine whether they have Alzheimer changes as well.
This helps improve clinical trials by including patients with more similar underlying microscopic changes in the brain. Another need from biomarkers is whether they can shed any light on mechanisms of disease that go beyond Lewy bodies, plaques and tangles. These include measures of different functions of neurons (i.e., brain cells). A promising sample of research in this area was also reviewed and generated an animated discussion.
The LBD researchers are planning a summary of this meeting for a medical journal, and also plan to incorporate these biomarkers into studies intended to develop new treatments for LBD.
An effort is being made to create simple blood tests for these purposes, but in the meantime people with LBD who participate in clinical research studies will likely be invited soon to participate in skin biopsies and cerebrospinal fluid collection as part of these studies. These tests provide very important information that can help clinical trials be successful.
The Biomarker Symposium is a great example of how education and research on LBD has continued despite the COVID pandemic. The LBDA has been pleased to be able to facilitate this type of program for the sake of improving the lives of our patients.
To view the recording of this 4 hour symposium, please visit our YouTube page, LBDAtv.
LBDA would like to thank Joseph Quinn, MD and David Irwin, MD for their help with this article.