Who should complete the pre-qualifying questionnaire for this study?

If you are a Care Partner to someone with Lewy body dementia and you feel you can answer “Yes” to any of the questions below, please take the prequalification questionnaire.

• Has the person you care for become suspicious or fearful?
• Is the person you care for seeing, hearing, tasting, or sensing things that are false, unreal, or unusual?
• Is the person you care for feeling, thinking, or believing things that are false, unreal, or unusual?

How will The Illumera Study be conducted?

The Illumera Study will begin with the Screening Period, lasting up to 30 days.

Study Participants and their Study Partners who qualify to participate will begin a Double-blind Treatment Period, during which Study Participants will be assigned to take one of two doses of the study drug or a placebo. “Double-blind” means that neither the Study Participants nor the study team will know which is being taken. Study Participants who complete the six-week Double-blind treatment period will have the option to enroll in an open-label extension study which will evaluate the study drug over a longer time. Study Participants who choose not to enroll in the extension study will have a Follow-up Period of 30 days for safety.

How is the study drug taken?

The study drug is a capsule that will be taken by mouth once a day.

Is there an obligation to continue if I complete the pre-qualifying questionnaire?

No. You may take the pre-qualifying questionnaire just to see if the person you care for might pre-qualify. Participation in a research study is completely voluntary at every step in the process. If pre-qualified, you will have the opportunity to submit your (the Care Partner’s) contact information to be contacted by the study staff. Submitting your information to a study center does not mean the person you care for must participate, and participation can be stopped at any time with no penalty to you or the person you care for.

Is medical insurance required?

No. All study-related clinic visits, procedures, and the study drug or placebo are at no charge.

If we qualify and enroll, what can we expect?

As Care Partner, you will be asked to:

• help answer questions about the Study Participant (symptoms and reactions to situations)
• help give the study medication
• attend study center visits
• be someone who sees the Study Participant often enough to tell the study doctor how they are doing

As a Study Participant, you will be asked to:

• complete all required visits or tell the study doctor or staff if you are unable to attend
• take the assigned dose of the study drug every day as directed
• follow all instructions from study staff
• refrain from taking any medication you have not discussed with the Study Doctor