Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 90
Updated:4/3/2019
Start Date:September 27, 2017
End Date:March 2020
Contact:Scott Stubbe
Email:sstubbe@acadia-pharm.com
Phone:858-261-2968

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A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

The purpose of this study is to evaluate the efficacy of pimavanserin by comparing
pimavanserin with placebo in preventing a relapse of psychotic symptoms in subjects with
dementia-related psychosis and who were stabilized after 12 weeks of open label pimavanserin
treatment.


Inclusion Criteria:

1. Meets criteria for All-cause Dementia according to NIA-AA guidelines

2. Meets clinical criteria for one of the following disorders: Dementia associated with
Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's
disease, Frontotemporal degeneration spectrum disorders, Vascular dementia

3. Has an MMSE score ≥6 and ≤24

4. Has had psychotic symptoms for at least 2 months

5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable

6. If the subject is female, she must not be pregnant or breastfeeding. She must also be
of non-childbearing potential or must agree to use a clinically acceptable method of
contraception for the duration of the study

Exclusion Criteria:

1. Has psychotic symptoms that are primarily attributable to a condition other than
dementia

2. Has had a recent major depressive episode

3. Has experienced suicidal ideation or behavior within 3 months prior to study
enrollment

4. Has evidence of a non-neurologic medical comorbidity or medication use that could
substantially impair cognition

5. Has a history of ischemic stroke within the last 12 months or any evidence of
hemorrhagic stroke

6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or
unexplained syncope

7. Has any of the following: greater than New York Heart Association (NYHA) Class 2
congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular
tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an
arrhythmia, an implantable cardiac defibrillator

8. Had a myocardial infarction within the last 6 months

9. Has a known personal or family history or symptoms of long QT syndrome

10. Has a significant unstable medical condition that could interfere with subject's
ability to complete the study or comply with study procedures

11. Requires treatment with a medication or other substance that is prohibited by the
protocol

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to
ensure that all criteria for study participation are met.
We found this trial at
43
sites
Knoxville, Tennessee 37920
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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Albany, New York 12208
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Aventura, FL
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Bangor, Maine 04401
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Boca Raton, FL
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Centerville, OH
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Charlottesville, Virginia 22903
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Chesterfield, Missouri 63141
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Costa Mesa, California 92626
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Danbury, Connecticut 06810
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Eatontown, New Jersey 07724
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Flowood, Mississippi 39232
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Fountain Valley, California 92708
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Fullerton, California 92835
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Houston, TX
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Indian Land, South Carolina 29707
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Irving, TX
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Las Vegas, Nevada 89128
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9000 Southwest 137th Avenue
Miami, Florida 33186
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Naples, Florida 34102
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New York, New York 10022
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Orange City, Florida 32763
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100 West Gore Street
Orlando, Florida 32806
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219 North Broad Street
Philadelphia, Pennsylvania 19107
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phillipsburg, New Jersey 08865
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Plano, TX
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Pompano Beach, Florida 33064
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54 Miller Street
Quincy, Massachusetts 02169
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Russe,
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Spartanburg, South Carolina 29307
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Staten Island, New York 10312
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Toms River, New Jersey 08755
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Willow Grove, Pennsylvania 19090
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Winfield, Illinois 60190
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