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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Axovant Sciences Ltd.
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT02910102
First received: September 16, 2016
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Alzheimer's Disease Dementia With Lewy Bodies Parkinson's Disease Dementia Drug: RVT-101 35 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RVT-101 35 mg
RVT-101 35 mg
Drug: RVT-101 35 mg
once daily, oral, 35-mg tablets
Placebo Comparator: Placebo
Placebo
Drug: Placebo
once daily, oral, matching tablets

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02910102

Contacts
Contact: Axovant Clinical Trials 646-677-6770

Locations
United States, Arizona
US101 Recruiting
Phoenix, Arizona, United States, 85013
United States, California
US118 Recruiting
Simi Valley, California, United States, 93065
US117 Recruiting
Temecula, California, United States, 92591
United States, Florida
US115 Recruiting
Boca Raton, Florida, United States, 33431
US109 Recruiting
Hallandale Beach, Florida, United States, 33009
US116 Recruiting
Miami, Florida, United States, 33137
US108 Recruiting
Pensacola, Florida, United States, 32502
United States, Georgia
US106 Recruiting
Columbus, Georgia, United States, 31909
United States, Indiana
US107 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Michigan
US102 Recruiting
Ann Arbor, Michigan, United States, 48106
United States, Ohio
US111 Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Chair: Ilise Lombardo, MD Axovant Sciences, Inc., Senior VP Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02910102     History of Changes
Other Study ID Numbers: RVT-101-2003
Study First Received: September 16, 2016
Last Updated: June 29, 2017

Keywords provided by Axovant Sciences Ltd.:
RVT-101
intepirdine
Alzheimer's disease
Dementia with Lewy bodies
Lewy body dementia
Parkinson's Disease Dementia

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Dementia
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 16, 2017