NCT02910102

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	RVT-101 35 mg	RVT-101 once daily, oral, 35-mg tablets
DRUG	Placebo	Placebo once daily, oral

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-09-21
• Last updated: 2020-04-28
• Results posted: 2020-04-28

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study