Brief description of the RVT-102-2001 Study
Nelotanserin for Potential Treatment of Visual Hallucinations in Dementia with Lewy Bodies (DLB) and Parkinson’s Disease Dementia (PDD)
An estimated 80% of people with dementia with Lewy bodies (DLB) and 70% of people with Parkinson’s disease dementia (PDD) experience visual hallucinations, a serious symptom where a person sees something that is not actually present. A clinical study is now evaluating nelotanserin, an investigational drug candidate, as a potential treatment for visual hallucinations in people with DLB or PDD. Learn more about local participation here:
RVT-102-2001 Study Longform Description
Nelotanserin for Potential Treatment of Visual Hallucinations in Dementia with Lewy Bodies (DLB) and Parkinson’s Disease Dementia (PDD)
What are Visual Hallucinations?
Visual hallucinations are characterized by someone believing that he or she sees things (for example, people, animals, objects, and/or shapes) that are not actually present. Visual hallucinations are often detailed and feel realistic to the person experiencing them – and because of their cognitive impairment some people may not be able to understand or differentiate the hallucinations from reality.
Visual hallucinations are a core feature of Lewy body dementia, which refers to both Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB): An estimated 80% of people with DLB and 70% of people with PDD experience visual hallucinations.
Visual hallucinations are not bothersome to some with DLB or PDD. For others, these hallucinations can be upsetting or frightening.
What is this study about?
This study is evaluating an experimental drug candidate, called nelotanserin, to determine its effectiveness in treating visual hallucinations in people with DLB or PDD.
What is involved?
Each participant will attend an initial screening visit plus 7 additional study visits over the course of approximately 12-14 weeks. During these visits, participants and their caregivers will complete study assessments and questionnaires. The study doctor will also evaluate and monitor participants for safety. Study-related care is provided at no cost, and transportation assistance to and from study visits may be available.
The study is “double-blind, placebo controlled,” meaning neither the researcher nor the person in the trial will know who is getting the study drug or a placebo (a study drug look-alike without any active study ingredients).
Participants who complete the study will be eligible for an open-label extension in which all participants will receive nelotanserin.
Who can participate?
An individual may be able to take part in the trial if he/she*:
• Is at least 50 years old
• Has been diagnosed with dementia with Lewy bodies (DLB) or Parkinson’s disease dementia (PDD)
• Has frequent visual hallucinations
* additional eligibility criteria apply
For more information call 913 749 0052 or click here.
Study Sponsor: Axovant Sciences
Study Sponsor:
Axovant Sciences