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

Use our guide to learn which trials are right for you!

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
219 North Broad Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
736 E Bullard Ave
Fresno, California 93710
559-437-9700
?
mi
from
Fresno, CA
Click here to add this to my saved trials
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...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chesterfield, Missouri 63141
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Costa Mesa, California 92626
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indian Land, South Carolina 29707
?
mi
from
Indian Land, SC
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89128
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
9000 Southwest 137th Avenue
Miami, Florida 33186
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phillipsburg, New Jersey 08865
?
mi
from
Phillipsburg, NJ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Pompano Beach, Florida 33064
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
54 Miller Street
Quincy, Massachusetts 02169
?
mi
from
Quincy, MA
Click here to add this to my saved trials
?
mi
from
Russe,
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Spartanburg, South Carolina 29307
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
Winfield, Illinois 60190
?
mi
from
Winfield, IL
Click here to add this to my saved trials