Males or females ages 55 to 84 at the time of the Screening Visit.
Study Participants must have either Parkinson’s disease with dementia or dementia with Lewy bodies.
Study Participants must be accompanied by a Care Partner (e.g., family member, social worker, case worker, or nurse) who is in contact with the Study Participant enough to accurately report on symptoms and participate in study assessments.
Study Participants must have had hallucinations and/or delusions for at least the past 2 months previous to Screening.
In The Illumera Study, we are evaluating an investigational drug for the treatment of psychosis symptoms (delusions and/or hallucinations) associated with Lewy body dementia. “Investigational” means that it has not been approved for use and that its safety and effectiveness are still being studied. Before new medications can be approved for public use, they must be tested in research studies like this one.
After potential participants and their Care Partners have learned about the study and signed an Informed Consent Form confirming this and their willingness to join the study, they will be screened to see if they meet the qualifications to participate. Screening may take up to 30 days.
Study Participants who meet all study requirements will be assigned to one of two doses or a placebo for a period of six weeks. People completing the study may have the option to enroll in a long-term open-label extension study in which all Study Participants will receive the active study drug and will be told at which dose.
Study Participants who do not proceed to the open-label extension study will enter a safety follow-up period of about 30 days after the treatment period ends with about 2 phone calls.
Seeing or hearing people or things that are not really there or having strong false beliefs are common elements of Lewy body dementia and can appear early in the course of the disease.
While these are among the most distressing symptoms of LBD, it is important to remember that they happen among LBD patients often and are a normal and expected aspect of this disease.
Finding new treatments to help people suffering from hallucinations and delusions associated with LBD would greatly benefit both the patient and their Care Partners.
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