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Trial record 1 of 1 for:    ACP-103-045 | United States
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325556
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
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.

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)
Estimated Enrollment : 356 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


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 period [ Time Frame: Up to 26 weeks ]

Secondary Outcome Measures :
  1. Time from randomization to discontinuation from the double-blind period for any reason [ Time Frame: Up to 26 weeks ]


Information from the National Library of Medicine

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03325556


Contacts
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Contact: Scott Stubbe 858-261-2968 sstubbe@acadia-pharm.com
Contact: Siobhan Shawbell 858-366-6207 sshawbell@acadia-pharm.com

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Locations
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United States, California
ATP Clinical Research Inc. Recruiting
Costa Mesa, California, United States, 92626
The Parkinson's and Movement Disorder Institute Withdrawn
Fountain Valley, California, United States, 92708
Neuro-Pain Medical Center Withdrawn
Fresno, California, United States, 93710
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
United States, Connecticut
Associated Neurologists, P.C. Withdrawn
Danbury, Connecticut, United States, 06810
Ki Health Partners, LLC, dba New England Institute for Clinical Research Withdrawn
Stamford, Connecticut, United States, 06905
United States, Florida
Visionary Investigators Network (Aventura Neurologic Associates) Terminated
Aventura, Florida, United States, 33180
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Premier Clinical Research Institute, Inc. Recruiting
Miami, Florida, United States, 33122
Visionary Investigators Network (First Choice Neurology Group) Recruiting
Miami, Florida, United States, 33176
Novel Clinical Research Center, LLC Recruiting
Miami, Florida, United States, 33186
Collier Neurologic Specialists LLC Recruiting
Naples, Florida, United States, 34102
Medical Research Group of Central Florida Withdrawn
Orange City, Florida, United States, 32763
Bioclinica Research Recruiting
Orlando, Florida, United States, 32806
Neurology Associates of Ormond Beach Withdrawn
Ormond Beach, Florida, United States, 32174
Quantum Laboratories Recruiting
Pompano Beach, Florida, United States, 33064
United States, Illinois
Neuroscience Research Institute Recruiting
Winfield, Illinois, United States, 60190
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. Recruiting
Kansas City, Kansas, United States, 66160
United States, Maine
Acadia Hospital Withdrawn
Bangor, Maine, United States, 04402
United States, Massachusetts
Alzheimer Disease Center Terminated
Quincy, Massachusetts, United States, 02169
United States, Mississippi
Precise Research Centers Withdrawn
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center Withdrawn
Jackson, Mississippi, United States, 39216
United States, Missouri
Clinical Research Professionals Recruiting
Chesterfield, Missouri, United States, 63005
Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research Recruiting
Saint Louis, Missouri, United States, 63132
United States, Nevada
Neurology Center of Las Vegas Terminated
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Memory Enhancement Center of America, Inc. Terminated
Eatontown, New Jersey, United States, 07724
Einstein Clinical, LLC Withdrawn
Phillipsburg, New Jersey, United States, 08865
BioBehavioral Health Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Neurological Associates of Albany, PC Recruiting
Albany, New York, United States, 12208
Manhattan Behavioral Medicine, PLLC Recruiting
New York, New York, United States, 10036
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
United States, Ohio
Dayton Center for Neurological Disorders Withdrawn
Centerville, Ohio, United States, 45459
Neuro-Behavioral Clinical Research, Inc. Recruiting
North Canton, Ohio, United States, 44720
United States, Pennsylvania
Drexel University Neurology Department Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Abington Neurological Associates Ltd. Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Metrolina Neurological Associates, PA Withdrawn
Indian Land, South Carolina, United States, 29707
BG Neurology LLC Withdrawn
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Houston Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
University Hills Clinical Research Withdrawn
Irving, Texas, United States, 75062
Advanced Clinical Research Associates Withdrawn
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Adult Neurology Recruiting
Charlottesville, Virginia, United States, 22903
United States, Washington
Booth Gardner Parkinson's Care Center Recruiting
Kirkland, Washington, United States, 98034
Bulgaria
Mental Health Center - Ruse EOOD Terminated
Russe, Bulgaria, 7003
MHAT Lyulin EAD - Department of Neurology Diseases Withdrawn
Sofia, Bulgaria, 1632
MHAT-Targovishte AD, Psychiatry Department Withdrawn
Targovishte, Bulgaria, 7700
DCC - Mladost M Varna OOD Withdrawn
Varna, Bulgaria, 9020
Chile
Psicomed Estudios Medicos Recruiting
Antofagasta, Chile, 1270244
Biomedica Research Group Recruiting
Santiago, Chile, 7500710
Especialidades Médicas L y S Recruiting
Santiago, Chile, 7560356
Czechia
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Králové, Czechia, 50005
Clintrial s.r.o. Recruiting
Praha 10, Czechia, 10000
AD71, s.r.o. Recruiting
Praha 10, Czechia, 10900
Vestra Clinics, s.r.o Recruiting
Rychnov nad Kněžnou, Czechia, 51601
France
CHU Henri Mondor - Centre d'investigation clinique Henri Mondor (CIC) Withdrawn
Creteil Cedex, France, 94010
Centre Memoire Ressources Recherche (CMRR), Hopital F. MITTERRAND Recruiting
Dijon Cedex, France, 21079
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay Recruiting
Marseille, France, 13385
Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche (CMRR) Withdrawn
Nice, France, 06100
Centre de Recherche du Gerontopole - CHU de Toulouse Recruiting
Toulouse, France, 31059
Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll Recruiting
Bad Homburg, Germany, 61348
Pharmakologisches Studienzentrum Chemnitz GmbH Recruiting
Mittweida, Germany, 09648
Klinik für Psychiatrie und Psychotherapie der Universität Tübingen Recruiting
Tuebingen, Germany, 72076
Italy
IRCCS Fatebenefratelli Dipartimento di Ricerca Clinica per la Malattia di Alzheimer Recruiting
Brescia, Italy, 25125
Azienda Ospedaliera di Padova Clinica Neurologica Recruiting
Padova, Italy, 35121
IRCCS Istituto Neurologico Casimiro Mondino Recruiting
Pavia, Italy, 27100
IRCCS San Raffaele Pisanna Recruiting
Rome, Italy, 00163
IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria Recruiting
Rome, Italy, 00179
Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA Recruiting
Rome, Italy, 00185
Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I Recruiting
Torino, Italy, 10126
Poland
Podlaskie Centrum Psychogeriatrii Recruiting
Bialystok, Poland, 15-756
Przychodnia Śródmieście Sp. z o.o. Recruiting
Bydgoszcz, Poland, 85-080
ISPL Wieslaw Jerzy Cubala Recruiting
Gdańsk, Poland, 80-438
Care Clinic Recruiting
Katowice, Poland, 40-060
Specjalistyczna Praktyka Lekarska Recruiting
Lublin, Poland, 20-582
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski Withdrawn
Olsztyn, Poland, 10-443
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Recruiting
Poznan, Poland, 61-853
NEURO-CARE Sp. z o.o. Sp. Komandytowa Recruiting
Siemianowice Śląskie, Poland, 41-100
Euromedis Sp z. o. o. Recruiting
Szczecin, Poland, 70-111
Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska Recruiting
Toruń, Poland, 87-100
Centrum Medyczne NeuroProtect Recruiting
Warszawa, Poland, 01-697
Serbia
Clinical center of Serbia, Clinic for Neurology Recruiting
Belgrade, Serbia, 11 000
Military Medical Academy, Clinic for Neurology Recruiting
Belgrade, Serbia, 11 000
Clinical Hospital Center Dr Dragisa Misovic-Dedinje Recruiting
Belgrade, Serbia, 11000
Institut of Mental Health Recruiting
Belgrade, Serbia, 11000
Psychiatric Clinic, Military Medical Academy Recruiting
Belgrade, Serbia, 11000
Clinic for Psychiatry, Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34 000
Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac Recruiting
Kragujevac, Serbia, 34 000
Clinic for Psychiatry Recruiting
Nis, Serbia, 18 000
General Hospital "Dr. Radivoj Simonovic" Sombor, Neurology Department Recruiting
Sombor, Serbia, 25000
Slovakia
MUDr. Beata Dupejova, neurologicka ambulancia s.r.o Terminated
Banska Bystrica, Slovakia, 974 04
Epamed s.r.o., Psychiatricka ambulancia Recruiting
Košice, Slovakia, 040 01
NEURES s.r.o. neurologicka ambulancia Terminated
Krompachy, Slovakia, 053 42
Centrum Zdravia R.B.K., s.r.o. Recruiting
Svidnik, Slovakia, 089 01
Crystal Comfort, s.r.o. Recruiting
Vranov nad Toplou, Slovakia, 093 01
Spain
Clinica IINA Recruiting
Barcelona, Spain, 08006
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital General de Cataluña Recruiting
Sant Cugat Del Vallès, Spain, 08195
Estudio de Psiquiatría Terminated
Sevilla, Spain, 41003
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Ukraine
Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1 Recruiting
Oleksandrivka, Odessa Region, Ukraine, 67513
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov" Recruiting
Dnipro, Ukraine, 49005
Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3" Recruiting
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 Recruiting
Kharkiv, Ukraine, 61068
Kherson Regional Psychiatric Hospital Recruiting
Kherson, Ukraine, 73488
Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine Withdrawn
Kiev, Ukraine, 04080
Lviv Regional State Clinical Psychiatric Hospital Recruiting
Lviv, Ukraine, 79021
Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18 Recruiting
Odesa, Ukraine, 65006
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev Recruiting
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 Recruiting
Vinnytsya, Ukraine, 21005
Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council" Recruiting
Zaporizhzhya, Ukraine, 69600
United Kingdom
Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre Terminated
Bath, United Kingdom, BA1 3NG
MAC Clinical Research - Blackpool Terminated
Blackpool, United Kingdom, FY2 0JH
St. Margaret's Hospital, Mental Health Unit Recruiting
Epping, United Kingdom, CM16 6TN
Stobhill Hospital Withdrawn
Glasgow, United Kingdom, G51 4TF
Re:Cognition Health Ltd. Recruiting
London, United Kingdom, W1G 9JF
MAC Clinical Research - Manchester Recruiting
Manchester, United Kingdom, M13 9NQ
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03325556     History of Changes
Other Study ID Numbers: ACP-103-045
2017-002227-13 ( EudraCT Number )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
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
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
Hallucinations
Delusions
Psychosis
Additional relevant MeSH terms:
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Dementia
Psychotic Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Pimavanserin
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