Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
NCT ID: NCT02910102
Last Updated: 2020-04-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2016-10-31
2017-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
NCT02669433
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
NCT02585934
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
NCT02928445
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
NCT02586909
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
NCT03305809
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each subject will be randomized 1:1 to one of the following sequences:
Sequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late treatment period
Sequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late treatment period
Treatment A = RVT-101 35 mg once daily.
Treatment B = Placebo once daily.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequence AB
RVT-101 35 mg in Period II and Placebo in Period IV
RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets
Placebo
Placebo once daily, oral
Sequence BA
Placebo in Period II and RVT-101 35 mg in Period IV
RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets
Placebo
Placebo once daily, oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets
Placebo
Placebo once daily, oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements Subjects must be on stable background acetylcholinesterase inhibitor therapy
Exclusion Criteria
50 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Axovant Sciences Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ilise Lombardo, MD
Role: STUDY_CHAIR
Axovant Sciences, Inc., Senior VP Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
US101
Phoenix, Arizona, United States
US118
Simi Valley, California, United States
US117
Temecula, California, United States
US115
Boca Raton, Florida, United States
US109
Hallandale, Florida, United States
US116
Miami, Florida, United States
US108
Pensacola, Florida, United States
US106
Columbus, Georgia, United States
US107
Indianapolis, Indiana, United States
US102
Ann Arbor, Michigan, United States
US111
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RVT-101-2003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.