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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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
154 Old US Highway 301
Ocala, Florida 34471
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Ocala, FL
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Birmingham, Alabama 35294
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Birmingham, AL
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114 Northwest Boca Raton Boulevard
Boca Raton, Florida 33486
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Boca Raton, FL
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101 Manning Drive
Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Cleveland, Ohio 44195
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Cleveland, OH
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Columbus, Ohio 43210
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Columbus, OH
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Fargo, North Dakota 58103
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Fargo, ND
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Lenexa, Kansas 66214
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Lenexa, KS
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129 Nebraska 2
Lincoln, Nebraska 68526
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Lincoln, NE
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Lincoln, Rhode Island 02865
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Lincoln, RI
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Little Rock, Arkansas 72205
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Little Rock, AR
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Maitland, Florida 32751
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Maitland, FL
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Memphis, Tennessee 38613
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Memphis, TN
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Orlando, Florida 32806
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Orlando, FL
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Rochester, Minnesota 55905
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Rochester, MN
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131 Old Highway 90 West
San Antonio, Texas 78229
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San Antonio, TX
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