NCT02910102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

September 16, 2016

Results QC Date

January 15, 2019

Last Update Submit

April 17, 2020

Conditions

Alzheimer's DiseaseDementia With Lewy BodiesParkinson's Disease Dementia

Keywords

RVT-101intepirdineAlzheimer's diseaseDementia with Lewy bodiesLewy body dementiaParkinson's Disease Dementia

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Baseline, 2 weeks

Study Arms (2)

Sequence AB

OTHER

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

Drug: RVT-101 35 mgDrug: Placebo

Sequence BA

OTHER

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

Drug: RVT-101 35 mgDrug: Placebo

Interventions

RVT-101 35 mgDRUG

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

Sequence ABSequence BA
PlaceboDRUG

Placebo once daily, oral

Sequence ABSequence BA

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

US101

Phoenix, Arizona, 85013, United States

Location

US118

Simi Valley, California, 93065, United States

Location

US117

Temecula, California, 92591, United States

Location

US115

Boca Raton, Florida, 33431, United States

Location

US109

Hallandale, Florida, 33009, United States

Location

US116

Miami, Florida, 33137, United States

Location

US108

Pensacola, Florida, 32502, United States

Location

US106

Columbus, Georgia, 31909, United States

Location

US107

Indianapolis, Indiana, 46202, United States

Location

US102

Ann Arbor, Michigan, 48106, United States

Location

US111

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseLewy Body Disease

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinoline

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Results Point of Contact

Title
Director, Clinical Development
Organization
Axovant Sciences, Inc.
clinicaltrials@axovant.com
1-833-296-8268

Study Officials

  • Ilise Lombardo, MD

    Axovant Sciences, Inc., Senior VP Clinical Research

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 28, 2020

Results First Posted

April 28, 2020

Record last verified: 2019-01

Locations

US(11)