Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Last updated: May 27, 2021
Sponsor: ACADIA Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Dementia

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT03325556
ACP-103-045
2017-002227-13
  • Ages 50-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withParkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer'sdisease, 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 beof non-childbearing potential or must agree to use a clinically acceptable method ofcontraception for the duration of the study

Exclusion

Exclusion Criteria:

  1. Has psychotic symptoms that are primarily attributable to a condition other thandementia
  2. Has had a recent major depressive episode
  3. Has experienced suicidal ideation or behavior within 3 months prior to studyenrollment
  4. Has evidence of a non-neurologic medical comorbidity or medication use that couldsubstantially impair cognition
  5. Has a history of ischemic stroke within the last 12 months or any evidence ofhemorrhagic stroke
  6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, orunexplained syncope
  7. Has any of the following: greater than New York Heart Association (NYHA) Class 2congestive heart failure, Grade 2 or greater angina pectoris, sustained ventriculartachycardia, ventricular fibrillation, torsade de pointes, syncope due to anarrhythmia, 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'sability to complete the study or comply with study procedures
  11. Requires treatment with a medication or other substance that is prohibited by theprotocol Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening toensure that all criteria for study participation are met.

Study Design

Total Participants: 392
Study Start date:
September 27, 2017
Estimated Completion Date:
October 30, 2019

Connect with a study center

  • Mental Health Center - Ruse EOOD

    Russe, 7003
    Bulgaria

    Site Not Available

  • MHAT Lyulin EAD - Department of Neurology Diseases

    Sofia, 1632
    Bulgaria

    Site Not Available

  • MHAT-Targovishte AD, Psychiatry Department

    Targovishte, 7700
    Bulgaria

    Site Not Available

  • DCC - Mladost M Varna OOD

    Varna, 9020
    Bulgaria

    Site Not Available

  • Psicomed Estudios Medicos

    Antofagasta, 1270244
    Chile

    Site Not Available

  • Biomedica Research Group

    Santiago, 7500710
    Chile

    Site Not Available

  • Especialidades Médicas L y S

    Santiago, 7560356
    Chile

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005
    Czechia

    Site Not Available

  • AD71, s.r.o.

    Praha 10, 10900
    Czechia

    Site Not Available

  • Clintrial s.r.o.

    Praha 10, 10000
    Czechia

    Site Not Available

  • Vestra Clinics, s.r.o

    Rychnov nad Kněžnou, 51601
    Czechia

    Site Not Available

  • CHU Henri Mondor - Centre d'investigation clinique Henri Mondor (CIC)

    Creteil Cedex, 94010
    France

    Site Not Available

  • Centre Memoire Ressources Recherche (CMRR), Hopital F. MITTERRAND

    Dijon Cedex, 21079
    France

    Site Not Available

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay

    Marseille, 13385
    France

    Site Not Available

  • Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche (CMRR)

    Nice, 06100
    France

    Site Not Available

  • Centre de Recherche du Gerontopole - CHU de Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348
    Germany

    Site Not Available

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09648
    Germany

    Site Not Available

  • Klinik für Psychiatrie und Psychotherapie der Universität Tübingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • IRCCS Fatebenefratelli Dipartimento di Ricerca Clinica per la Malattia di Alzheimer

    Brescia, 25125
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova Clinica Neurologica

    Padova, 35121
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Casimiro Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria

    Rome, 00179
    Italy

    Site Not Available

  • IRCCS San Raffaele Pisanna

    Rome, 00163
    Italy

    Site Not Available

  • Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA

    Rome, 00185
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I

    Torino, 10126
    Italy

    Site Not Available

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756
    Poland

    Site Not Available

  • Przychodnia Śródmieście Sp. z o.o.

    Bydgoszcz, 85-080
    Poland

    Site Not Available

  • ISPL Wieslaw Jerzy Cubala

    Gdańsk, 80-438
    Poland

    Site Not Available

  • Care Clinic

    Katowice, 40-060
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska

    Lublin, 20-582
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

    Olsztyn, 10-443
    Poland

    Site Not Available

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

    Poznan, 61-853
    Poland

    Site Not Available

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Siemianowice Śląskie, 41-100
    Poland

    Site Not Available

  • Euromedis Sp z. o. o.

    Szczecin, 70-111
    Poland

    Site Not Available

  • Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska

    Toruń, 87-100
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warszawa, 01-697
    Poland

    Site Not Available

  • Clinical Hospital Center Dr Dragisa Misovic-Dedinje

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical center of Serbia, Clinic for Neurology

    Belgrade, 11 000
    Serbia

    Site Not Available

  • Institut of Mental Health

    Belgrade, 11000
    Serbia

    Site Not Available

  • Military Medical Academy, Clinic for Neurology

    Belgrade, 11 000
    Serbia

    Site Not Available

  • Psychiatric Clinic, Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinic for Psychiatry, Clinical Center Kragujevac

    Kragujevac, 34 000
    Serbia

    Site Not Available

  • Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac

    Kragujevac, 34 000
    Serbia

    Site Not Available

  • Clinic for Psychiatry

    Nis, 18 000
    Serbia

    Site Not Available

  • General Hospital "Dr. Radivoj Simonovic" Sombor, Neurology Department

    Sombor, 25000
    Serbia

    Site Not Available

  • MUDr. Beata Dupejova, neurologicka ambulancia s.r.o

    Banska Bystrica, 974 04
    Slovakia

    Site Not Available

  • Epamed s.r.o., Psychiatricka ambulancia

    Kosice-Stare Mesto, 040 01
    Slovakia

    Site Not Available

  • Epamed s.r.o., Psychiatricka ambulancia

    Košice, 040 01
    Slovakia

    Site Not Available

  • NEURES s.r.o. neurologicka ambulancia

    Krompachy, 053 42
    Slovakia

    Site Not Available

  • Centrum Zdravia R.B.K., s.r.o.

    Svidnik, 089 01
    Slovakia

    Site Not Available

  • Crystal Comfort, s.r.o.

    Vranov nad Toplou, 093 01
    Slovakia

    Site Not Available

  • Clinica IINA

    Barcelona, 08006
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General de Cataluña

    Sant Cugat Del Vallès, 08195
    Spain

    Site Not Available

  • Estudio de Psiquiatría

    Sevilla, 41003
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1

    Oleksandrivka, Odessa Region 67513
    Ukraine

    Site Not Available

  • Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1

    S. Oleksandrivka, Odessa Region 67513
    Ukraine

    Site Not Available

  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"

    Dnipro, 49005
    Ukraine

    Site Not Available

  • Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • 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, 61068
    Ukraine

    Site Not Available

  • Kherson Regional Psychiatric Hospital

    Kherson, 73488
    Ukraine

    Site Not Available

  • Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine

    Kiev, 04080
    Ukraine

    Site Not Available

  • Lviv Regional State Clinical Psychiatric Hospital

    Lviv, 79021
    Ukraine

    Site Not Available

  • Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18

    Odesa, 65006
    Ukraine

    Site Not Available

  • Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev

    Poltava, 36013
    Ukraine

    Site Not Available

  • 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, 21005
    Ukraine

    Site Not Available

  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"

    Zaporizhzhya, 69600
    Ukraine

    Site Not Available

  • Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • MAC Clinical Research - Blackpool

    Blackpool, FY2 0JH
    United Kingdom

    Site Not Available

  • St. Margaret's Hospital, Mental Health Unit

    Epping, CM16 6TN
    United Kingdom

    Site Not Available

  • Stobhill Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Re:Cognition Health Ltd.

    London, W1G 9JF
    United Kingdom

    Site Not Available

  • MAC Clinical Research - Manchester

    Manchester, M13 9NQ
    United Kingdom

    Site Not Available

  • ATP Clinical Research Inc.

    Costa Mesa, California 92626
    United States

    Site Not Available

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Associated Neurologists, P.C.

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Ki Health Partners, LLC, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Visionary Investigators Network (Aventura Neurologic Associates)

    Aventura, Florida 33180
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Quantum Laboratories

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Novel Clinical Research Center, LLC

    Miami, Florida 33186
    United States

    Site Not Available

  • Premier Clinical Research Institute, Inc.

    Miami, Florida 33122
    United States

    Site Not Available

  • Visionary Investigators Network (First Choice Neurology Group)

    Miami, Florida 33176
    United States

    Site Not Available

  • Collier Neurologic Specialists LLC

    Naples, Florida 34102
    United States

    Site Not Available

  • Medical Research Group of Central Florida

    Orange City, Florida 32763
    United States

    Site Not Available

  • Bioclinica Research

    Orlando, Florida 32806
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Quantum Laboratories

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Neuroscience Research Institute

    Winfield, Illinois 60190
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Acadia Hospital

    Bangor, Maine 04402
    United States

    Site Not Available

  • Alzheimer Disease Center

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Alzheimer Disease Center

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Precise Research Centers

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research

    Saint Louis, Missouri 63132
    United States

    Site Not Available

  • Neurology Center of Las Vegas

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • Einstein Clinical, LLC

    Phillipsburg, New Jersey 08865
    United States

    Site Not Available

  • BioBehavioral Health

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Neurological Associates of Albany, PC

    Albany, New York 12208
    United States

    Site Not Available

  • Manhattan Behavioral Medicine, PLLC

    New York, New York 10036
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Dayton Center for Neurological Disorders

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio 44720
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Abington Neurological Associates Ltd.

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Metrolina Neurological Associates, PA

    Indian Land, South Carolina 29707
    United States

    Site Not Available

  • BG Neurology LLC

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • University Hills Clinical Research

    Irving, Texas 75062
    United States

    Site Not Available

  • Advanced Clinical Research Associates

    Plano, Texas 75093
    United States

    Site Not Available

  • University of Virginia Adult Neurology

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Booth Gardner Parkinson's Care Center

    Kirkland, Washington 98034
    United States

    Site Not Available

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