Living with Lewy body dementia (LBD) can be challenging in many ways. While cognition and movement problems are often discussed, many people with LBD also experience hallucinations or delusions—for example, seeing people who are not really there or strongly believing things that are not true. These symptoms are known as LBD psychosis, and they are common in both dementia with Lewy bodies and Parkinson’s disease dementia.
While these symptoms are not always disturbing, hallucinations and delusions may be frightening, confusing, and disruptive—not only for the person living with LBD, but also for family members and care partners. Although treatments exist, options remain limited, and not every treatment works well for every person. That is why new research studies focused on Lewy body dementia psychosis are so important.
One such study has recently launched: the ILLUMERA Study.
What is the ILLUMERA Study?
The ILLUMERA Study is a clinical research study testing an investigational medication designed to help reduce hallucinations and delusions in people with Lewy body dementia. An investigational medication is one that is still being studied and has not yet been approved for general use. Studies like ILLUMERA help researchers learn whether a potential treatment is safe and effective.
The goals of this study are twofold:
- To see whether the study medication can reduce psychosis symptoms in LBD
- To gather information that may lead to better treatment options in the future
Who can participate?
A person may be able to join the ILLUMERA Study if they:
- Are 55 to 84 years old
- Have been diagnosed with Lewy body dementia, including both dementia with Lewy bodies (DLB) or Parkinson’s disease dementia (PDD)
- Have had hallucinations and/or delusions for at least two months
- Have a care partner (such as a spouse, adult child, or close friend) who can attend study visits and help with participation
The study team will carefully review each person’s situation during a screening process to make sure the study is a good fit.
What does participation involve?
People who are interested in the study will first go through a screening period of up to 30 days, which includes one clinic visit. This visit helps the study doctors determine whether someone is eligible.
If eligible, participants will enter a 6-week treatment period. During this time:
- Participants are randomly assigned to receive one of two doses of the study medication or a placebo (a placebo looks like the study drug but does not contain active medication, i.e., a “sugar pill”).
- Neither participants nor study staff know who receives which treatment during the study.
Over the six weeks, participants will attend five clinic visits. At these visits, study staff will:
- Assess hallucinations and delusions using standard clinical tools
- Conduct medical exams and laboratory tests
- Monitor safety and answer questions
The role of the care partner
Care partners play an essential role in the ILLUMERA Study. They help by:
- Attending study visits
- Providing information about symptoms and daily functioning
- Supporting the participant throughout the study
Their involvement helps researchers get a more complete and accurate picture of how symptoms affect daily life.
Are there costs?
There is no cost to participate in the ILLUMERA Study. Study visits, exams, and the study medication are provided at no charge. Reimbursement for some study-related expenses may also be available.
After the initial six-week study ends, some participants may be eligible to continue in an extension study, in which everyone receives the active medication.
Where is the study taking place?
The ILLUMERA Study is being conducted at multiple research sites across the United States. Each site has trained study doctors and staff who specialize in caring for people with neurological conditions.
Why clinical trials matter
Clinical trials are how progress happens. Today’s treatments exist because people and families before us chose to participate in research. By joining a study like ILLUMERA, participants contribute to knowledge that may improve care for future generations affected by Lewy body dementia. While participation may or may not directly help an individual participant, every participant helps move LBD research forward.
How to learn more
If you may be interested, you can learn more by following this link to learn more about the study on the LBDA clinical trials page and view study sites and contact information.
And if you are interested in being notified directly via email when new studies launch, consider signing up for the Lewy Trial Tracker.
