Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
NCT ID: NCT03325556
Last Updated: 2021-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
392 participants
INTERVENTIONAL
2017-09-27
2019-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo, tablets, once daily by mouth
Drug - Pimavanserin
Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Interventions
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Placebo
Placebo, tablets, once daily by mouth
Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
90 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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ATP Clinical Research Inc.
Costa Mesa, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Visionary Investigators Network (Aventura Neurologic Associates)
Aventura, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Visionary Investigators Network (First Choice Neurology Group)
Miami, Florida, United States
Novel Clinical Research Center, LLC
Miami, Florida, United States
Collier Neurologic Specialists LLC
Naples, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Quantum Laboratories
Pompano Beach, Florida, United States
Neuroscience Research Institute
Winfield, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Alzheimer Disease Center
Quincy, Massachusetts, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
St Louis, Missouri, United States
Neurology Center of Las Vegas
Las Vegas, Nevada, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
BioBehavioral Health
Toms River, New Jersey, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Abington Neurological Associates Ltd.
Willow Grove, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Virginia Adult Neurology
Charlottesville, Virginia, United States
Mental Health Center - Ruse EOOD
Rousse, , Bulgaria
Psicomed Estudios Medicos
Antofagasta, , Chile
Biomedica Research Group
Santiago, , Chile
Especialidades Médicas L y S
Santiago, , Chile
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Clintrial s.r.o.
Prague, , Czechia
AD71, s.r.o.
Prague, , Czechia
Vestra Clinics, s.r.o
Rychnov nad Kněžnou, , Czechia
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
Marseille, , France
Centre de Recherche du Gerontopole - CHU de Toulouse
Toulouse, , France
Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
Tübingen, , Germany
Azienda Ospedaliera di Padova Clinica Neurologica
Padua, , Italy
IRCCS San Raffaele Pisanna
Rome, , Italy
IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
Rome, , Italy
Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
Rome, , Italy
Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
Torino, , Italy
Przychodnia Śródmieście Sp. z o.o.
Bydgoszcz, , Poland
ISPL Wieslaw Jerzy Cubala
Gdansk, , Poland
Care Clinic
Katowice, , Poland
Specjalistyczna Praktyka Lekarska
Lublin, , Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, , Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, , Poland
Euromedis Sp z. o. o.
Szczecin, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Clinical center of Serbia, Clinic for Neurology
Belgrade, , Serbia
Military Medical Academy, Clinic for Neurology
Belgrade, , Serbia
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
Belgrade, , Serbia
Institut of Mental Health
Belgrade, , Serbia
Psychiatric Clinic, Military Medical Academy
Belgrade, , Serbia
Clinic for Psychiatry, Clinical Center Kragujevac
Kragujevac, , Serbia
Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
Kragujevac, , Serbia
Clinic for Psychiatry
Niš, , Serbia
MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
Banská Bystrica, , Slovakia
Epamed s.r.o., Psychiatricka ambulancia
Košice, , Slovakia
NEURES s.r.o. neurologicka ambulancia
Krompachy, , Slovakia
Centrum Zdravia R.B.K., s.r.o.
Svidník, , Slovakia
Crystal Comfort, s.r.o.
Vranov nad Topľou, , Slovakia
Clinica IINA
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General de Cataluña
Sant Cugat del Vallès, , Spain
Estudio de Psiquiatría
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
Oleksandrivka, Odesa Oblast, Ukraine
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
Dnipro, , Ukraine
Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
Kharkiv, , Ukraine
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
Kherson Regional Psychiatric Hospital
Kherson, , Ukraine
Lviv Regional State Clinical Psychiatric Hospital
Lviv, , Ukraine
Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
Odesa, , Ukraine
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
Poltava, , Ukraine
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
Vinnytsia, , Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
Zaporizhzhya, , Ukraine
Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
Bath, , United Kingdom
MAC Clinical Research - Blackpool
Blackpool, , United Kingdom
Re:Cognition Health Ltd.
London, , United Kingdom
MAC Clinical Research - Manchester
Manchester, , United Kingdom
Countries
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References
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Cummings JL, Ismail Z, Dickerson BC, Ballard C, Grossberg G, McEvoy B, Foff E, Atri A. Development and assessment of a brief screening tool for psychosis in dementia. Alzheimers Dement (Amst). 2021 Dec 7;13(1):e12254. doi: 10.1002/dad2.12254. eCollection 2021.
Tariot PN, Cummings JL, Soto-Martin ME, Ballard C, Erten-Lyons D, Sultzer DL, Devanand DP, Weintraub D, McEvoy B, Youakim JM, Stankovic S, Foff EP. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021 Jul 22;385(4):309-319. doi: 10.1056/NEJMoa2034634.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Tariot P, et al. HARMONY relapse-prevention study: pimavanserin significantly prolongs time to relapse of dementia-related psychosis. J Prev Alz Dis. 2019; 6(suppl 1):S30-S31
Other Identifiers
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2017-002227-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACP-103-045
Identifier Type: -
Identifier Source: org_study_id
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