Dementia With Lewy Bodies, Lewy Body Dementia, Parkinson's Disease Dementia, REM Sleep Behavior Disorder, Visual Hallucinations
Conditions
Keywords
Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Visual hallucinations, REM sleep behavior disorder
Brief summary
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
Detailed description
This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.
Interventions
DRUGNelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Sponsors
Axovant Sciences Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with LBD who completed a previous nelotanserin VH or RBD study
Exclusion criteria
* Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. | 24 weeks |
| Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment. | 24 weeks |
Countries
United States
Outcome results
None listed