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
Chesterfield, Missouri 63141
?
mi
from
Chesterfield, MO
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
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
219 North Broad Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
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