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



Status:Completed
Conditions:Alzheimer Disease, Parkinsons Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 89
Updated:12/29/2017
Start Date:October 2016
End Date:November 2017

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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

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.

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.

Key Inclusion Criteria:

1. Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia
with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

2. Mini Mental State Examination score 14 to 26

3. Gait impairment, as assessed by history gathered by the clinical investigator and
quantitative measurements

4. Subjects must be on stable background acetylcholinesterase inhibitor therapy

Key Exclusion Criteria:

1. History and/or evidence of any other CNS disorder that could be interpreted as a cause
of dementia (in the opinion of the investigator)

2. Any clinically relevant concomitant disease which, in the opinion of the investigator,
makes the subject unsuitable for inclusion in the study.
We found this trial at
11
sites
Columbus, Georgia 31909
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Columbus, GA
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Ann Arbor, Michigan 48106
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Ann Arbor, MI
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Boca Raton, Florida 33431
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Boca Raton, FL
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Columbus, Ohio 43210
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Columbus, OH
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Hallandale Beach, Florida 33009
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Hallandale Beach, FL
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Miami, Florida 33137
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Miami, FL
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Pensacola, Florida 32502
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Pensacola, FL
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3509 East Shea Boulevard
Phoenix, Arizona 85013
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Phoenix, AZ
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118 American Road
Simi Valley, California 93065
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Simi Valley, CA
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Temecula, California 92591
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Temecula, CA
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