Dementia With Lewy Bodies Clinical Trial
Official title:
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Verified date | February 2018 |
Source | Axovant Sciences Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.
Status | Terminated |
Enrollment | 240 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 86 Years |
Eligibility |
Inclusion Criteria: - Participated in the lead-in study RVT-101-2001. Exclusion Criteria: - Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study. |
Country | Name | City | State |
---|---|---|---|
Canada | CA200 | Toronto | Ontario |
France | FR957 | Lille | Nord |
France | FR959 | Paris | |
France | FR960 | Paris | |
France | FR953 | Saint-Herblain | |
France | FR950 | Strasbourg | |
France | FR952 | Toulouse | Haute-Garonne |
France | FR955 | VandÅ“uvre-lès-Nancy | |
France | FR951 | Villeurbanne | Rhone |
Italy | IT302 | Brescia | Lombardia |
Italy | IT306 | Brescia | |
Italy | IT300 | Genova | Liguria |
Italy | IT301 | Milano | |
Italy | IT304 | Tricase | Lecce |
Italy | IT305 | Venice | |
Netherlands | NE402 | Amsterdam | Noord-Holland |
Netherlands | NE401 | Den Bosch | |
Spain | SP600 | Barcelona | |
Spain | SP605 | Barcelona | |
United Kingdom | UK807 | Bristol | |
United Kingdom | UK801 | Cambridge | Cambridgeshire |
United Kingdom | UK806 | Dundee | |
United Kingdom | UK808 | Epping | Essex |
United Kingdom | UK805 | Isleworth | |
United Kingdom | UK800 | London | |
United Kingdom | UK809 | London | |
United Kingdom | UK802 | Manchester | |
United Kingdom | UK803 | Newcastle upon Tyne | |
United Kingdom | UK804 | Southampton | Hampshire |
United States | US136 | Atlanta | Georgia |
United States | US104 | Boca Raton | Florida |
United States | US100 | Chapel Hill | North Carolina |
United States | US101 | Charlottesville | Virginia |
United States | US110 | Cleveland | Ohio |
United States | US106 | Columbus | Ohio |
United States | US141 | Englewood | Colorado |
United States | US118 | Indianapolis | Indiana |
United States | US111 | Jacksonville | Florida |
United States | US105 | Lexington | Kentucky |
United States | US109 | New York | New York |
United States | US119 | Orange | California |
United States | US122 | Orlando | Florida |
United States | US134 | Oxnard | California |
United States | US137 | Palm Beach Gardens | Florida |
United States | US108 | Phoenix | Arizona |
United States | US138 | Phoenix | Arizona |
United States | US131 | Portland | Oregon |
United States | US130 | Quincy | Massachusetts |
United States | US133 | Rancho Mirage | California |
United States | US102 | Rochester | Minnesota |
United States | US140 | Sacramento | California |
United States | US139 | Sun City | Arizona |
United States | US126 | Tampa | Florida |
United States | US125 | Tucson | Arizona |
United States | US123 | Washington | District of Columbia |
United States | US120 | Willow Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Axovant Sciences Ltd. |
United States, Canada, France, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments | 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 |
NCT02871427 -
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
|
Phase 2 | |
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 |