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

Axovant Sciences Ltd.38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer's Disease Dementia With Lewy Bodies Parkinson's Disease Dementia

Interventions

RVT-101 35 mgDRUG

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

PlaceboDRUG

Placebo once daily, oral

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (11)

US101

Phoenix, Arizona, United States

US118

Simi Valley, California, United States

US117

Temecula, California, United States

US115

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

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.

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

Time frame: Baseline, 2 weeks

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.

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.

Time frame: Baseline, 2 weeks

Data from ClinicalTrials.gov

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