Dementia With Lewy Bodies Clinical Trial
Official title:
An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
Verified date | March 2019 |
Source | Axovant Sciences Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 80 |
Est. completion date | January 17, 2019 |
Est. primary completion date | January 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | US120 | Birmingham | Alabama |
United States | US114 | Boca Raton | Florida |
United States | US101 | Chapel Hill | North Carolina |
United States | US111 | Cincinnati | Ohio |
United States | US104 | Cleveland | Ohio |
United States | US105 | Columbus | Ohio |
United States | US147 | Fargo | North Dakota |
United States | US107 | Indianapolis | Indiana |
United States | US132 | Lenexa | Kansas |
United States | US129 | Lincoln | Nebraska |
United States | US173 | Lincoln | Rhode Island |
United States | US143 | Little Rock | Arkansas |
United States | US180 | Maitland | Florida |
United States | US128 | Memphis | Tennessee |
United States | US154 | Ocala | Florida |
United States | US113 | Orlando | Florida |
United States | US152 | Ormond Beach | Florida |
United States | US103 | Rochester | Minnesota |
United States | US131 | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Axovant Sciences Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03996460 -
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
|
Phase 2 | |
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Recruiting |
NCT02194816 -
Modifiable Variables in Parkinsonism (MVP)
|
||
Active, not recruiting |
NCT01208675 -
The Swedish BioFINDER Study
|
||
Completed |
NCT03538522 -
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
|
Phase 2 | |
Recruiting |
NCT03672448 -
The China Longitudinal Aging Study of Cognitive Impairment
|
||
Completed |
NCT01340001 -
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies
|
N/A | |
Not yet recruiting |
NCT04760860 -
Terazosin for Dementia With Lewy Bodies
|
Phase 1/Phase 2 | |
Completed |
NCT02910102 -
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
|
Phase 2 | |
Terminated |
NCT02928445 -
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
|
Phase 2/Phase 3 | |
Completed |
NCT05188105 -
Alpha tACS in Dementia With Lewy Bodies
|
N/A | |
Active, not recruiting |
NCT04167813 -
Trial of Ondansetron as a Parkinson's HAllucinations Treatment
|
Phase 2 | |
Enrolling by invitation |
NCT04954183 -
Development of an EEG Diagnostic for Alzheimer's Disease
|
||
Recruiting |
NCT05326750 -
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
|
N/A | |
Completed |
NCT01023672 -
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
|
Phase 4 | |
Completed |
NCT03907748 -
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
|
N/A | |
Completed |
NCT04649164 -
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
|
N/A | |
Recruiting |
NCT03924414 -
Trial of Parkinson's And Zoledronic Acid
|
Phase 4 | |
Completed |
NCT05885620 -
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
|
N/A | |
Not yet recruiting |
NCT04555629 -
Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)
|
N/A |