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Trial record 10 of 10 for:    SB-742457

Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02910102
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):
Axovant Sciences Ltd.

Brief Summary:
This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia With Lewy Bodies Parkinson's Disease Dementia Drug: RVT-101 35 mg Drug: Placebo Phase 2

Detailed Description:

To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative gait and balance parameters.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: RVT-101 35 mg
RVT-101 35 mg
Drug: RVT-101 35 mg
once daily, oral, 35-mg tablets

Placebo Comparator: Placebo
Drug: Placebo
once daily, oral, matching tablets

Primary Outcome Measures :
  1. Change in quantitative gait measurements from baseline to the end of each double-blind treatment period based on computerized gait assessment tools. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidence of adverse events, and reported changes in physical examinations, vital signs, electrocardiograms, and clinical laboratory assessments from baseline to the end of each double-blind treatment period. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).
  2. Mini Mental State Examination score 14 to 26
  3. Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements
  4. Subjects must be on stable background acetylcholinesterase inhibitor therapy

Key Exclusion Criteria:

  1. History and/or evidence of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator)
  2. Any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02910102

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United States, Arizona
Phoenix, Arizona, United States, 85013
United States, California
Simi Valley, California, United States, 93065
Temecula, California, United States, 92591
United States, Florida
Boca Raton, Florida, United States, 33431
Hallandale Beach, Florida, United States, 33009
Miami, Florida, United States, 33137
Pensacola, Florida, United States, 32502
United States, Georgia
Columbus, Georgia, United States, 31909
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Michigan
Ann Arbor, Michigan, United States, 48106
United States, Ohio
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Axovant Sciences Ltd.
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Study Chair: Ilise Lombardo, MD Axovant Sciences, Inc., Senior VP Clinical Research

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Responsible Party: Axovant Sciences Ltd. Identifier: NCT02910102     History of Changes
Other Study ID Numbers: RVT-101-2003
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Keywords provided by Axovant Sciences Ltd.:
Alzheimer's disease
Dementia with Lewy bodies
Lewy body dementia
Parkinson's Disease Dementia
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders