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
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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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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Bangor, Maine 04401
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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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Indian Land, South Carolina 29707
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Knoxville, Tennessee 37920
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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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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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