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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910102
• Other study ID #: RVT-101-2003
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2019
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets
• Placebo
Placebo once daily, oral

Locations

Country	Name	City	State
United States	US102	Ann Arbor	Michigan
United States	US115	Boca Raton	Florida
United States	US106	Columbus	Georgia
United States	US111	Columbus	Ohio
United States	US109	Hallandale Beach	Florida
United States	US107	Indianapolis	Indiana
United States	US116	Miami	Florida
United States	US108	Pensacola	Florida
United States	US101	Phoenix	Arizona
United States	US118	Simi Valley	California
United States	US117	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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