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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 December 2016 by Axovant Sciences Ltd.
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT02910102
First received: September 16, 2016
Last updated: December 20, 2016
Last verified: December 2016
  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: Double Blind (Subject, Caregiver, 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 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, Florida
US103 Recruiting
Gainesville, Florida, United States, 32610
United States, Michigan
US102 Recruiting
Ann Arbor, Michigan, United States, 48106
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: December 20, 2016

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 March 23, 2017