- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575052
A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bourgas, Bulgaria, 8000
- Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
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Pleven, Bulgaria, 5800
- UMHAT Psych clin for gen psychiatry and addictions
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Sofia, Bulgaria, 1408
- DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
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Varna, Bulgaria, 9000
- Diagnostic Consultative Centre, 2, N. Vaptzarov Street
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Varna, Bulgaria, 9000
- Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd
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Vratsa, Bulgaria, 3000
- Mental Health Center Vratza EOOD, 1 Belasitsa St
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Bogota, Colombia, 111166
- Centro de Investigaciones del Sistema Nervioso
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Antioquia
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Bello, Antioquia, Colombia, 51053
- E.S.E. Hospital Mental de Antioquia
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Atlantico
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Barranquilla, Atlantico, Colombia, 080020
- Centr Investigaciones y Proyectos en Neurociencias
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Risaralda
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Pereira, Risaralda, Colombia, 66001
- Psynapsis Salud Mental S.A.
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Kladno, Czechia, 27204
- BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113
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Olomouc, Czechia, 77900
- Fakultni nemocnice Olomouc
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Plzen, Czechia, 31200
- A-shine s.r.o./ Lekarna Centrum
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Praha 10, Czechia, 10200
- AD71, s.r.o.,/Hostivarska Iekarna
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Praha 5, Czechia, 1500
- AXON Clinical
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Praha 6, Czechia, 16010
- Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
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Říčany, Czechia, 25101
- AD71, s.r.o., /,Lekarna DPS Recruiting
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Tbilisi, Georgia, 0114
- Pineo Medical Ecosystem LTD
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Tbilisi, Georgia, 0160
- Health Institute LLC
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Tbilisi, Georgia, 0112
- Petre Sarajishvili Institute of Neurology LLC
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Tbilisi, Georgia, 0159
- Tbilisi Heart and Vascular Clinic Ltd
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Tbilisi, Georgia, 0179
- S. Khechinashvili University Hospital LLC
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Coahuila
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Saltillo, Coahuila, Mexico, 25000
- Hospital Universitario Saltillo
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Delegacion Tlalpan
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Ciudad de Mexico, Delegacion Tlalpan, Mexico, 14269
- Instituto Nacional de Neurologia y Neurocirugia
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64460
- Centro Regional para Adulto Mayor, Hsp Univ, JEG
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Monterrey, Nuevo Leon, Mexico, 64620
- Clinicos y Especialidades Medicas
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Monterrey, Nuevo Leon, Mexico, 64988
- Christus Muguerza Hospital Sur
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Bialystok, Poland, 15-404
- MlynowaMed SP Psych Dr. Joanna Lazarcyck
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Białystok, Poland, 15-464
- Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski
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Bydgoszcz, Poland, 85-080
- Przychodnia Srodmiescie Sp. z.o.o.
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Gdańsk, Poland, 80-438
- ISPL Wieslaw Jerzy Cubala
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Katowice, Poland, 40-123
- NZOZ Wielospecjalistyczna Poradnia Lekarska Synap
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Katowice, Poland, 40-282
- Silmedic Sp. z.o.o.
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Kraków, Poland, 31-505
- Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
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Poznań, Poland, 61-485
- Centrum Medyczne HCP Sp. z.o.o.
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Pruszcz Gdański, Poland, 83-000
- NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
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Siemianowice Śląskie, Poland, 41-100
- Neuro-Care
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Siemianowice Śląskie, Poland, 41-100
- Neuro-Care Sp. Z.o.o. sp. Komandytowa
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Sochaczew, Poland, 96-500
- RCMed Oddzial Sochaczew, ul. _eromskiego 41A
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Poznan
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Plewiska, Poznan, Poland, 62-064
- Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych
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Constanta, Romania, 900123
- Spitalul clinic CF Constanta, Sectia Neurologie
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Iasi, Romania, 700004
- Med Anima SRL, Clinica de psihiatrie
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Sibiu, Romania, 550281
- S.C. Carpe Diem SRL
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Cluj
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Cluj-Napoca, Cluj, Romania, 400012
- Spitalul Clinic Judetean de Urgenta Cluj-Napoca
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Moscow, Russian Federation, 115522
- Mental Health Research Center
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Novosibirsk, Russian Federation, 630054
- City Clinical Hospital #34
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Roshchino, Russian Federation, 188820
- Leningrad Regional Psychoneurological Dispensary
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Saint Petersburg, Russian Federation, 190121
- St. Nicholas the Wonder Worker Psychiatric Hospital
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Saint Petersburg, Russian Federation, 193167
- FSBI NMRC PN n.a. V.M. Bekhterev
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Saint Petersburg, Russian Federation, 197341
- City Psychiatric Hospital #3
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Samara, Russian Federation, 443016
- Samara Psychiatric Hospital
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Saratov, Russian Federation, 410028
- Saratov City Clinical Hospital V. I. Razumovsky
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Smolensk, Russian Federation, 214019
- Smolensk State Medical University
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Stavropol', Russian Federation, 355038
- Stavropol Regional Clin Spec Psych Hospital #1
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Kochubeev District
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Tonnel'nyy, Kochubeev District, Russian Federation, 357034
- Regional Specialized Psychiatric Hospital #2
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Krasnoyarksk Region
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Krasnoyarsk, Krasnoyarksk Region, Russian Federation, 660037
- Federal Siberian Sci Clinical Center of Med and Bio
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Tomsk Region
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Tomsk, Tomsk Region, Russian Federation, 634009
- Clinic "Hundred Years"
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Belgrade, Serbia, 11000
- Military Medical Academy
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Belgrade, Serbia, 11000
- Clinical Center of Serbia, Clinic for Psychiatry
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Belgrade, Serbia, 11000
- CHC Dr Dragisa Misovic- Dedinje
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Belgrade, Serbia, 18000
- Clinic for Psychiatric Diseases Dr. Laza Lazarevic
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Belgrade, Serbia, 34000
- Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
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Kovin, Serbia, 26220
- Special Hospital for Psychiatric Diseases "Kovin"
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Kragujevac, Serbia, 34000
- Clinical Center Kragujevac, Clinic for Neurology
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Kragujevac, Serbia, 34000
- Clinical Center Kragujevac, Clinic of Psychiatry
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Toponica, Serbia, 18202
- Clinical Center Nis, Clinic for Psychiatry
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Valjevo, Serbia, 14000
- General Hospital Valjevo, Department for Neurology
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Gauteng
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Pretoria, Gauteng, South Africa, 0014
- Neurology Practice
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Sandton, Gauteng, South Africa, 2146
- Dr. Stanley Lipshitz Clinic Inc.
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Western Cape
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Durbanville, Western Cape, South Africa, 7500
- Flexivest Fourteen Research Centre Potocnik F C V
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Dnipro, Ukraine, 49005
- Dnipr Regional Clinical Hospital n.a. Mechnikov
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Dnipro, Ukraine, 49005
- I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital
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Dnipro, Ukraine, 49128
- Dnipropetrovsk Regional Rehabilitation Hospital
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Ivano-Frankivsk, Ukraine, 76014
- Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
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Kharkiv, Ukraine, 61068
- Institute of Neruology, Nat Acad of Med Sci of UKR
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Kharkiv, Ukraine, 61068
- Institute of Neurology
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Kharkiv, Ukraine, 61068
- Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str
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Kyiv, Ukraine, 04080
- Kyiv Regional Medical Incorp. Psychiatria, Center
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Kyiv, Ukraine, 8630
- Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str
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Ternopil', Ukraine, 46027
- Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
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Vinnytsia, Ukraine, 21037
- Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #7, Female Department #10, Vinnytsya, National Medical University n.a. M.I.Pyrogov, 109 Pyrogova str.
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Zaporizhzhya, Ukraine, 69600
- Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
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Zaporizhzhya, Ukraine, 69600
- Zaporizhzhya Reg. Hospital, Neurology Dpt
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Arizona
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Gilbert, Arizona, United States, 85296
- Cognitive Clinical Trials
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California
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Costa Mesa, California, United States, 92626
- ATP Clinical Research, Inc.
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Santa Ana, California, United States, 92705
- Syrentis Clinical Research
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Florida
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Hialeah, Florida, United States, 33012
- Reliable Clinical Research, LLC
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Hialeah, Florida, United States, 33012
- Indago Research & Health Center Inc
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Loxahatchee Groves, Florida, United States, 33470
- Axcess Medical Research
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Miami, Florida, United States, 33165
- Future Care Solution, LLC
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Miami, Florida, United States, 33122
- Premier Clinical Research Institute, Inc.
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Miami, Florida, United States, 33125
- Global Medical Institutes
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Miami, Florida, United States, 33165
- MediClear Medical & Research Center, Inc.
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Miami, Florida, United States, 33186
- Novel Clinical Research LLC
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North Palm Beach, Florida, United States, 33408
- Laszlo J Mate, MD, PA
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Tampa, Florida, United States, 33613
- University of South Florida
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The Villages, Florida, United States, 32162
- Synexus Clinical Research US
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Massachusetts
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Newton, Massachusetts, United States, 02459
- Boston Center Memory
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Nebraska
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Papillion, Nebraska, United States, 68046
- Cognitive Clinical Trials LLC
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New Jersey
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Mount Arlington, New Jersey, United States, 07856
- The NeuroCognitive Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Hospital
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Ohio
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Shaker Heights, Ohio, United States, 44122
- Insight Clinical Trials LLC
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Suburban Research Associates
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Central for Biomedical Research, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
- The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
- The subject must provide written (if capable) informed assent
Subject requires some or complete assistance with one or more of the following:
- Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
- Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):
- Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
- Dementia with Lewy bodies (DLB)
- All-cause dementia, possible or probable Alzheimer's disease (AD)
- Frontotemporal degeneration spectrum disorders, including possible or probable:
i. Behavioral variant frontotemporal dementia
ii. Progressive supranuclear palsy
iii. Corticobasal degeneration
e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)
- Has a designated study partner/caregiver
- Can come to the clinic for study visits with a study partner/caregiver
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent.
- If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)
Exclusion Criteria:
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
- Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
- Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:
- intracranial mass lesion
- vascular malformation
- evidence of >4 hemosiderin deposits
- The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor.
- Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo, tablets, once daily by mouth (provided as two placebo tablets)
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Experimental: Drug - Pimavanserin
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Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-emergent adverse events (TEAEs)
Time Frame: Treatment Period: 8 weeks
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Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease
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Treatment Period: 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
Time Frame: Treatment Period: 8 weeks
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Treatment Period: 8 weeks
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Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE)
Time Frame: Treatment Period: 8 weeks
|
Treatment Period: 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurodegenerative Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pimavanserin
Other Study ID Numbers
- ACP-103-046
- 2017-003536-36 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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