Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder



Status:Terminated
Conditions:Alzheimer Disease, Parkinsons Disease, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:3/29/2019
Start Date:October 20, 2016
End Date:January 17, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the
treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder
(RBD) in subjects with Lewy body dementia (LBD).

This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs.
Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to
participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once
daily for 24 weeks.

Inclusion Criteria:

- Subjects with LBD who completed a previous nelotanserin VH or RBD study

Exclusion Criteria:

- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid,
gastrointestinal, renal, hematologic or other medical disorder
We found this trial at
19
sites
US131
131 Old Highway 90 West
San Antonio, Texas 78229
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San Antonio, TX
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US120
Birmingham, Alabama 35294
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Birmingham, AL
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US114
114 Northwest Boca Raton Boulevard
Boca Raton, Florida 33486
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Boca Raton, FL
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US101
101 Manning Drive
Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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US111
Cincinnati, Ohio 45229
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Cincinnati, OH
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US104
Cleveland, Ohio 44195
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Cleveland, OH
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US105
Columbus, Ohio 43210
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Columbus, OH
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US147
Fargo, North Dakota 58103
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Fargo, ND
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US107
Indianapolis, Indiana 46202
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Indianapolis, IN
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US132
Lenexa, Kansas 66214
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Lenexa, KS
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US129
129 Nebraska 2
Lincoln, Nebraska 68526
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Lincoln, NE
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US173
Lincoln, Rhode Island 02865
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Lincoln, RI
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US143
Little Rock, Arkansas 72205
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Little Rock, AR
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US180
Maitland, Florida 32751
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Maitland, FL
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US128
Memphis, Tennessee 38613
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Memphis, TN
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US154
154 Old US Highway 301
Ocala, Florida 34471
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Ocala, FL
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US113
Orlando, Florida 32806
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Orlando, FL
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US152
Ormond Beach, Florida 32174
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Ormond Beach, FL
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US103
Rochester, Minnesota 55905
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Rochester, MN
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