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

• ClinicalTrials.gov Identifier: NCT02910102
• Recruitment Status: Completed
• First Posted: September 21, 2016
• Results First Posted: April 28, 2020
• Last Update Posted: April 28, 2020
• Sponsor: Axovant Sciences Ltd.
• Information provided by (Responsible Party): Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Description

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Sequence AB; RVT-101 35 mg in Period II and Placebo in Period IV	Drug: RVT-101 35 mg; RVT-101 once daily, oral, 35-mg tablets; Drug: Placebo; Placebo once daily, oral
Sequence BA; Placebo in Period II and RVT-101 35 mg in Period IV	Drug: RVT-101 35 mg; RVT-101 once daily, oral, 35-mg tablets; Drug: Placebo; Placebo once daily, oral

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

US101

Phoenix, Arizona, United States, 85013

United States, California

US118

Simi Valley, California, United States, 93065

US117

Temecula, California, United States, 92591

United States, Florida

US115

Boca Raton, Florida, United States, 33431

US109

Hallandale Beach, Florida, United States, 33009

US116

Miami, Florida, United States, 33137

US108

Pensacola, Florida, United States, 32502

United States, Georgia

US106

Columbus, Georgia, United States, 31909

United States, Indiana

US107

Indianapolis, Indiana, United States, 46202

United States, Michigan

US102

Ann Arbor, Michigan, United States, 48106

United States, Ohio

US111

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Axovant Sciences Ltd.

Investigators

• Study Chair: Ilise Lombardo, MD; Axovant Sciences, Inc., Senior VP Clinical Research

  Study Documents (Full-Text)

Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):

Study Protocol  [PDF] February 7, 2017

Statistical Analysis Plan  [PDF] November 29, 2017

More Information

• Responsible Party: Axovant Sciences Ltd.
• ClinicalTrials.gov Identifier: NCT02910102
• Other Study ID Numbers: RVT-101-2003
• First Posted: September 21, 2016
• Results First Posted: April 28, 2020
• Last Update Posted: April 28, 2020
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sio Gene Therapies ( 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; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders