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
US147
Fargo, North Dakota 58103
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Fargo, ND
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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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from
Cincinnati, OH
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US104
Cleveland, Ohio 44195
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from
Cleveland, OH
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US105
Columbus, Ohio 43210
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from
Columbus, OH
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US107
Indianapolis, Indiana 46202
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from
Indianapolis, IN
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US132
Lenexa, Kansas 66214
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from
Lenexa, KS
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US129
129 Nebraska 2
Lincoln, Nebraska 68526
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from
Lincoln, NE
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US173
Lincoln, Rhode Island 02865
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from
Lincoln, RI
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US143
Little Rock, Arkansas 72205
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from
Little Rock, AR
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US180
Maitland, Florida 32751
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from
Maitland, FL
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US128
Memphis, Tennessee 38613
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from
Memphis, TN
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US154
154 Old US Highway 301
Ocala, Florida 34471
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from
Ocala, FL
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US113
Orlando, Florida 32806
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from
Orlando, FL
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US152
Ormond Beach, Florida 32174
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from
Ormond Beach, FL
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US103
Rochester, Minnesota 55905
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from
Rochester, MN
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US131
131 Old Highway 90 West
San Antonio, Texas 78229
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mi
from
San Antonio, TX
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