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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RVT-101 35 mg
Placebo
Sponsored by
Axovant Sciences Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring RVT-101, intepirdine, Alzheimer's disease, Dementia with Lewy bodies, Lewy body dementia, Parkinson's Disease Dementia

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US101
  • US118
  • US117
  • US115
  • US109
  • US116
  • US108
  • US106
  • US107
  • US102
  • US111

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sequence AB

Sequence BA

Arm Description

RVT-101 35 mg in Period II and Placebo in Period IV

Placebo in Period II and RVT-101 35 mg in Period IV

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2016
Last Updated
April 17, 2020
Sponsor
Axovant Sciences Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02910102
Brief Title
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axovant Sciences Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia
Keywords
RVT-101, intepirdine, Alzheimer's disease, Dementia with Lewy bodies, Lewy body dementia, Parkinson's Disease Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence AB
Arm Type
Other
Arm Description
RVT-101 35 mg in Period II and Placebo in Period IV
Arm Title
Sequence BA
Arm Type
Other
Arm Description
Placebo in Period II and RVT-101 35 mg in Period IV
Intervention Type
Drug
Intervention Name(s)
RVT-101 35 mg
Intervention Description
RVT-101 once daily, oral, 35-mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily, oral
Primary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilise Lombardo, MD
Organizational Affiliation
Axovant Sciences, Inc., Senior VP Clinical Research
Official's Role
Study Chair
Facility Information:
Facility Name
US101
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
US118
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
US117
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
US115
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
US109
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
US116
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
US108
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
US106
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
US107
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
US102
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
US111
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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