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NCT Number: NCT02910102

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Dementia With Lewy Bodies Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson's Disease Dementia Parkinsonian Disorders Synucleinopathies Tauopathies

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

US101, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

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

Key Exclusion Criteria:

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

Treatment and study plan

RVT-101 35 mg

Drug

RVT-101 once daily, oral, 35-mg tablets

Placebo

Drug

Placebo once daily, oral

Primary outcomes

  1. Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

    Time frame: Baseline, 2 weeks

    Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period

  2. Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

    Time frame: Baseline, 2 weeks

    Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period.

Sponsors and collaborators

Lead sponsor

Axovant Sciences Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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