Clinical Trials: New Data and New Opportunities

April 5, 2023

This is an exciting time to follow clinical research in Lewy body dementia. This month we are highlighting updates from recent studies, along with new opportunities to participate in trials of potential new medications and diagnostic tests.

New Data on LBD Caregiver Health

Providing care for a person with Lewy body dementia (LBD) has some unique challenges. Fluctuations in cognition, alertness and attention mean that caregiving can be unpredictable from day to day. REM sleep behavior disorder (RBD) can disrupt the sleep of both the person with LBD and the caregiver. These challenges have a very real impact on the well-being and health of LBD caregivers. Caregiver strain is higher in LBD than in Alzheimer’s and other dementias. Caregiver strain refers to the social, emotional, and physical effects of caregiving on the caregiver. However, data on specific health conditions faced by LBD caregivers has been lacking.

With the support of the LBDA and other advocacy organizations, Dr. Jori Fleisher of Rush University and colleagues surveyed hundreds of people providing care for individuals with LBD, which includes both dementia with Lewy bodies and Parkinson’s disease dementia. Some of you reading this may have even participated in the survey. The results, published last month in the medical journal Alzheimer Disease & Associated Disorders, are illuminating.

More than a third of LBD caregivers reported having either hypertension (high blood pressure), depression, or back pain. Younger caregivers, in particular, commonly reported depression and back pain, with these conditions affecting approximately half of the respondents aged 18 to 54. The rates of depression among all age groups were much higher than expected, approximately three times higher than the general rate among Medicare beneficiaries, and double the rates found among caregivers for people with other forms of dementia. High rates of back pain, particularly among younger caregivers, is surprising and may reflect challenges such as extra physical demands of caregiving such as assisting someone in or out of a chair, and lack of time for self-care such as exercise and stress reduction strategies.

Investigational drugs for LBD

From research funders to academic researchers and study participants, the LBD field is in relentless pursuit of safe and effective treatments. And LBDA is committed to bringing you clinical trial news.

In the closing days of February, the pharmaceutical company Aptinyx reported results from a Phase 2 trial of their investigational drug NYX-458, which unfortunately did not show promise. In this study, volunteers diagnosed with cognitive impairment and Parkinson’s disease or dementia with Lewy bodies took either the study drug or a placebo once daily for twelve weeks. Treatment with the study drug did not result in clinically meaningful improvements in either daily functioning or cognition.

The LBDA sincerely appreciates all the patients who took part in the trial, their families and caregivers who supported them, and the efforts of the scientists to develop and test the investigational drug. The community learns from each and every trial, whether the drug is ultimately successful or not. Those lessons are applied to future studies, which build the knowledge base that will eventually result in the first FDA-approved treatment for those with Lewy body dementias.

Progress on a skin test

While the promise of safe and effective therapeutics is obvious, doctors also need reliable tests for LBD.

NIH has awarded CND Life Sciences a small business innovation research (SBIR) grant for a new clinical trial of a skin biopsy test to evaluate whether it can differentiate between early-stage DLB and early-stage Alzheimer’s. Another aim of the study is to determine whether the test can provide valuable information about the severity and progression of DLB.

How can I get involved?

Progress in finding new tests and treatments for LBD depends on people like you. While participating in a clinical trial is not right for everyone, each study brings us closer to realizing our vision of a cure for Lewy body dementia and quality support for those still living with the disease.

To find more studies, visit

Even better, fill out the confidential Lewy Trial Tracker survey to tell us more about what types of studies interest you. You’ll automatically be signed up to receive regular updates straight to your email inbox when new trials are launched.



Reference: Fleisher JE, et al. 2023. Family Caregiver Comorbidities in Lewy Body Dementia Versus Alzheimer Disease and Associated Disorders. Alzheimer Disease & Associated Disorders 37(1):p 42-49, January–March 2023. | DOI: 10.1097/WAD.0000000000000535