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

Phase 2

Completed

• Conditions: Dementia With Lewy Bodies; Parkinson's Disease Dementia; Alzheimer's Disease
• Interventions: Drug: RVT-101 35 mg; Drug: Placebo

• Registration Number: NCT02910102
• Lead Sponsor: Axovant Sciences Ltd.

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.

Study Timeline

• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Study Start: 2016-10
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-01
• Results First Submitted: 2019-01-15
• Results First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Results First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence AB	Placebo	RVT-101 35 mg in Period II and Placebo in Period IV
Sequence BA	RVT-101 35 mg	Placebo in Period II and RVT-101 35 mg in Period IV
Sequence AB	RVT-101 35 mg	RVT-101 35 mg in Period II and Placebo in Period IV
Sequence BA	Placebo	Placebo in Period II and RVT-101 35 mg in Period IV

Primary Outcome Measures

Name	Time	Method
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.	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.
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.	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

Trial Locations

Locations (11)

US101; 🇺🇸 Phoenix, Arizona, United States

US118; 🇺🇸 Simi Valley, California, United States

US117; 🇺🇸 Temecula, California, United States

US115; 🇺🇸 Boca Raton, Florida, United States

US109; 🇺🇸 Hallandale Beach, Florida, United States

US116; 🇺🇸 Miami, Florida, United States

US108; 🇺🇸 Pensacola, Florida, United States

US106; 🇺🇸 Columbus, Georgia, United States

US107; 🇺🇸 Indianapolis, Indiana, United States

US102; 🇺🇸 Ann Arbor, Michigan, United States

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