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Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03325556
Recruitment Status : Completed
First Posted : October 30, 2017
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.

Condition or disease Intervention/treatment Phase
Dementia-related Psychosis Drug: Placebo Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : October 30, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth

Experimental: Drug - Pimavanserin Drug: Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth

Drug: Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Primary Outcome Measures :
  1. Time From Randomization to Relapse in the Double-blind (DB) Period [ Time Frame: From randomization in the DB period through 26 weeks ]

    The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR).

    Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis.

    SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening.

    A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.

Secondary Outcome Measures :
  1. Time From Randomization to Discontinuation From the DB Period for Any Reason [ Time Frame: From randomization in the DB period through 26 weeks ]
    The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03325556

Hide Hide 83 study locations
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United States, California
ATP Clinical Research Inc.
Costa Mesa, California, United States, 92626
Neurology Center of North Orange County
Fullerton, California, United States, 92835
United States, Florida
Visionary Investigators Network (Aventura Neurologic Associates)
Aventura, Florida, United States, 33180
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Premier Clinical Research Institute, Inc.
Miami, Florida, United States, 33122
Visionary Investigators Network (First Choice Neurology Group)
Miami, Florida, United States, 33176
Novel Clinical Research Center, LLC
Miami, Florida, United States, 33186
Collier Neurologic Specialists LLC
Naples, Florida, United States, 34102
Bioclinica Research
Orlando, Florida, United States, 32806
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
Quantum Laboratories
Pompano Beach, Florida, United States, 33064
United States, Illinois
Neuroscience Research Institute
Winfield, Illinois, United States, 60190
United States, Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Alzheimer Disease Center
Quincy, Massachusetts, United States, 02169
United States, Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
Saint Louis, Missouri, United States, 63132
United States, Nevada
Neurology Center of Las Vegas
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
BioBehavioral Health
Toms River, New Jersey, United States, 08755
United States, New York
Neurological Associates of Albany, PC
Albany, New York, United States, 12208
Manhattan Behavioral Medicine, PLLC
New York, New York, United States, 10036
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States, 44720
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Abington Neurological Associates Ltd.
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
United States, Virginia
University of Virginia Adult Neurology
Charlottesville, Virginia, United States, 22903
Mental Health Center - Ruse EOOD
Russe, Bulgaria, 7003
Psicomed Estudios Medicos
Antofagasta, Chile, 1270244
Biomedica Research Group
Santiago, Chile, 7500710
Especialidades Médicas L y S
Santiago, Chile, 7560356
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 50005
Clintrial s.r.o.
Praha 10, Czechia, 10000
AD71, s.r.o.
Praha 10, Czechia, 10900
Vestra Clinics, s.r.o
Rychnov nad Kněžnou, Czechia, 51601
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
Marseille, France, 13385
Centre de Recherche du Gerontopole - CHU de Toulouse
Toulouse, France, 31059
Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
Tuebingen, Germany, 72076
Azienda Ospedaliera di Padova Clinica Neurologica
Padova, Italy, 35121
IRCCS San Raffaele Pisanna
Rome, Italy, 00163
IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
Rome, Italy, 00179
Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
Rome, Italy, 00185
Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
Torino, Italy, 10126
Przychodnia Śródmieście Sp. z o.o.
Bydgoszcz, Poland, 85-080
ISPL Wieslaw Jerzy Cubala
Gdańsk, Poland, 80-438
Care Clinic
Katowice, Poland, 40-060
Specjalistyczna Praktyka Lekarska
Lublin, Poland, 20-582
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, Poland, 61-853
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, Poland, 41-100
Euromedis Sp z. o. o.
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-697
Clinical center of Serbia, Clinic for Neurology
Belgrade, Serbia, 11 000
Military Medical Academy, Clinic for Neurology
Belgrade, Serbia, 11 000
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
Belgrade, Serbia, 11000
Institut of Mental Health
Belgrade, Serbia, 11000
Psychiatric Clinic, Military Medical Academy
Belgrade, Serbia, 11000
Clinic for Psychiatry, Clinical Center Kragujevac
Kragujevac, Serbia, 34 000
Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
Kragujevac, Serbia, 34 000
Clinic for Psychiatry
Nis, Serbia, 18 000
MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
Banska Bystrica, Slovakia, 974 04
Epamed s.r.o., Psychiatricka ambulancia
Košice, Slovakia, 040 01
NEURES s.r.o. neurologicka ambulancia
Krompachy, Slovakia, 053 42
Centrum Zdravia R.B.K., s.r.o.
Svidnik, Slovakia, 089 01
Crystal Comfort, s.r.o.
Vranov nad Toplou, Slovakia, 093 01
Clinica IINA
Barcelona, Spain, 08006
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital General de Cataluña
Sant Cugat Del Vallès, Spain, 08195
Estudio de Psiquiatría
Sevilla, Spain, 41003
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
Oleksandrivka, Odessa Region, Ukraine, 67513
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
Dnipro, Ukraine, 49005
Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
Kharkiv, Ukraine, 61068
State Institution "Institute of Neurology, Psychiatry, and Narcology of the National Academy of Medical Sciences of Ukraine", Department of Clinical, Social, and Paediatric Psychiatry
Kharkiv, Ukraine, 61068
Kherson Regional Psychiatric Hospital
Kherson, Ukraine, 73488
Lviv Regional State Clinical Psychiatric Hospital
Lviv, Ukraine, 79021
Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
Odesa, Ukraine, 65006
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
Poltava, Ukraine, 36013
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic
Vinnytsya, Ukraine, 21005
Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
Zaporizhzhya, Ukraine, 69600
United Kingdom
Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
Bath, United Kingdom, BA1 3NG
MAC Clinical Research - Blackpool
Blackpool, United Kingdom, FY2 0JH
Re:Cognition Health Ltd.
London, United Kingdom, W1G 9JF
MAC Clinical Research - Manchester
Manchester, United Kingdom, M13 9NQ
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  Study Documents (Full-Text)

Documents provided by ACADIA Pharmaceuticals Inc.:
Study Protocol  [PDF] August 16, 2018
Statistical Analysis Plan  [PDF] July 26, 2019

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT03325556    
Other Study ID Numbers: ACP-103-045
2017-002227-13 ( EudraCT Number )
First Posted: October 30, 2017    Key Record Dates
Results First Posted: June 21, 2021
Last Update Posted: June 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ACADIA Pharmaceuticals Inc.:
Dementia-related psychosis
Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Alzheimer's disease
Behavioral variant frontotemporal dementia
Progressive supranuclear palsy
Corticobasal degeneration
Vascular dementia
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action