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Trial record 1 of 1 for:    ACP-103-046
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A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

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: NCT03575052
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

Condition or disease Intervention/treatment Phase
Neuropsychiatric Symptoms Related to Neurodegenerative Disease Drug: Pimavanserin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug - Pimavanserin Drug: Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth (provided as two placebo tablets)




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: Treatment Period: 8 weeks ]
    Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease


Secondary Outcome Measures :
  1. Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) [ Time Frame: Treatment Period: 8 weeks ]
  2. Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE) [ Time Frame: Treatment Period: 8 weeks ]


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:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

    1. The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
    2. The subject must provide written (if capable) informed assent
  2. Subject requires some or complete assistance with one or more of the following:

    1. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
    2. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
  3. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):

    1. Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
    2. Dementia with Lewy bodies (DLB)
    3. All-cause dementia, possible or probable Alzheimer's disease (AD)
    4. 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)

  4. Has a designated study partner/caregiver
  5. Can come to the clinic for study visits with a study partner/caregiver
  6. 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.
  7. 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:

  1. Is in hospice, is receiving end-of-life palliative care, or is bedridden
  2. Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
  3. 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
  4. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
  5. Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:

    1. intracranial mass lesion
    2. vascular malformation
    3. evidence of >4 hemosiderin deposits
  6. 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.
  7. 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).


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): NCT03575052


Contacts
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Contact: Brian Raether 858-768-6074 braether@acadia-pharm.com
Contact: Jason Do 858-261-2971 jdo@acadia-pharm.com

Locations
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United States, California
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
United States, Florida
Indago Research & Health Center Inc Recruiting
Hialeah, Florida, United States, 33012
Future Care Solution, LLC Recruiting
Miami, Florida, United States, 33165
Laszlo J Mate, MD, PA Active, not recruiting
North Palm Beach, Florida, United States, 33408
University of South Florida Active, not recruiting
Tampa, Florida, United States, 33613
Bioclinica Research Recruiting
The Villages, Florida, United States, 32162
United States, Massachusetts
Boston Center Memory Terminated
Newton, Massachusetts, United States, 02459
United States, New Jersey
The NeuroCognitive Institute Active, not recruiting
Mount Arlington, New Jersey, United States, 07856
United States, New York
Parker Jewish Institute for Health Care & Rehabilitation Active, not recruiting
New Hyde Park, New York, United States, 11040
United States, North Carolina
UNC Hospital Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Insight Clinical Trials LLC Recruiting
Shaker Heights, Ohio, United States, 44122
United States, Pennsylvania
Suburban Research Associates Active, not recruiting
Media, Pennsylvania, United States, 19063
Bulgaria
Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero Recruiting
Bourgas, Bulgaria, 8000
UMHAT Psych clin for gen psychiatry and addictions Recruiting
Pleven, Bulgaria, 5800
DCC Sv. Vrach and Sv. Sv. Kozma and Damyan Recruiting
Sofia, Bulgaria, 1408
Diagnostic Consultative Centre, 2, N. Vaptzarov Street Recruiting
Varna, Bulgaria, 9000
Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd Recruiting
Varna, Bulgaria, 9000
Mental Health Center Vratza EOOD, 1 Belasitsa St Recruiting
Vratsa, Bulgaria, 3000
Colombia
E.S.E. Hospital Mental de Antioquia Recruiting
Bello, Antioquia, Colombia, 51053
Centr Investigaciones y Proyectos en Neurociencias Recruiting
Barranquilla, Atlantico, Colombia, 080020
Psynapsis Salud Mental S.A. Recruiting
Pereira, Risaralda, Colombia, 66001
Centro de Investigaciones del Sistema Nervioso Recruiting
Bogota, Colombia, 111166
Czechia
BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113 Recruiting
Kladno, Czechia, 27204
Fakultni nemocnice Olomouc Active, not recruiting
Olomouc, Czechia, 77900
Vseobecna fakultni nemocnice v Praze Recruiting
Praha 2, Czechia, 12808
Axon Clinical Active, not recruiting
Praha 5, Czechia, 1500
Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1 Recruiting
Praha 6, Czechia, 16010
Georgia
Petre Sarajishvili Institute of Neurology LLC Recruiting
Tbilisi, Georgia, 0112
Pineo Medical Ecosystem LTD Recruiting
Tbilisi, Georgia, 0114
Tbilisi Heart and Vascular Clinic LTD Recruiting
Tbilisi, Georgia, 0159
Health Institute LLC Recruiting
Tbilisi, Georgia, 0160
S. Khechinashvili University Hospital LLC Active, not recruiting
Tbilisi, Georgia, 0179
Mexico
Hospital Universitario Saltillo Recruiting
Saltillo, Coahuila, Mexico, 25000
Instituto Nacional de Neurologia y Neurocirugia Recruiting
Ciudad de Mexico, Delegacion Tlalpan, Mexico, 14269
Centro Regional para Adulto Mayor, Hsp Univ, JEG Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Clinicos y Especialidades Medicas Recruiting
Monterrey, Nuevo Leon, Mexico, 64620
Christus Muguerza Hospital Sur Recruiting
Monterrey, Nuevo Leon, Mexico, 64988
Poland
Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych Active, not recruiting
Plewiska, Poznan, Poland, 62-064
MlynowaMed SP Psych Dr. Joanna Lazarcyck Recruiting
Bialystok, Poland, 15-404
Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski Recruiting
Białystok, Poland, 15-464
SPPZOZ w Choroszczy, Apteka Szpitalna Active, not recruiting
Choroszcz, Poland, 16-070
NZOZ Wielospecjalistyczna Poradnia Lekarska Synap Active, not recruiting
Katowice, Poland, 40-123
Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3 Recruiting
Kraków, Poland, 31-505
NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz Active, not recruiting
Pruszcz Gdański, Poland, 83-000
RCMed Oddzial Sochaczew, ul. _eromskiego 41A Recruiting
Sochaczew, Poland, 96-500
Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Recruiting
Cluj-Napoca, Cluj, Romania, 400012
Spitalul Pius Brînzeu Timișoara, Dep Neurologie Recruiting
Timisoara, Timis, Romania, 300723
Spitalul clinic CF Constanta, Sectia Neurologie Recruiting
Constanta, Romania, 900123
Med Anima SRL, Clinica de psihiatrie Recruiting
Iasi, Romania, 700004
Spitalul Judetean de Urgenta Piatra Neamt Recruiting
Piatra Neamt, Romania, 610136
S.C. Carpe Diem SRL Recruiting
Sibiu, Romania, 550281
Russian Federation
Regional Specialized Psychiatric Hospital #2 Recruiting
Tonnel'nyy, Kochubeev District, Russian Federation, 357034
Federal Siberian Sci Clinical Center of Med and Bio Recruiting
Krasnoyarsk, Krasnoyarksk Region, Russian Federation, 660037
Clinic "Hundred Years" Recruiting
Tomsk, Tomsk Region, Russian Federation, 634009
Mental Health Research Center Recruiting
Moscow, Russian Federation, 115522
City Clinical Hospital #34 Recruiting
Novosibirsk, Russian Federation, 630054
Leningrad Regional Psychoneurological Dispensary Recruiting
Roshchino, Russian Federation, 188820
St. Nicholas the Wonder Worker Psychiatric Hospital Recruiting
Saint Petersburg, Russian Federation, 190121
Samara Psychiatric Hospital Recruiting
Samara, Russian Federation, 443016
Saratov City Clinical Hospital V. I. Razumovsky Recruiting
Saratov, Russian Federation, 410028
Stavropol Regional Clin Spec Psych Hospital #1 Recruiting
Stavropol', Russian Federation, 355038
Serbia
Clinical Center of Serbia, Clinic for Psychiatry Recruiting
Belgrade, Serbia, 11000
Clinic for Psychiatric Diseases Dr. Laza Lazarevic Recruiting
Belgrade, Serbia, 18000
Klinicki Centar Srbije (KCS)- Klinika za nerurologiju Recruiting
Belgrade, Serbia, 34000
Special Hospital for Psychiatric Diseases "Kovin" Recruiting
Kovin, Serbia, 26220
Clinical Center Kragujevac, Clinic for Neurology Recruiting
Kragujevac, Serbia, 34000
Clinical Center Kragujevac, Clinic of Psychiatry Recruiting
Kragujevac, Serbia, 34000
Clinical Center Nis, Clinic for Psychiatry Recruiting
Toponica, Serbia, 18202
General Hospital Valjevo, Department for Neurology Recruiting
Valjevo, Serbia, 14000
South Africa
Neurology Practice Recruiting
Pretoria, Gauteng, South Africa, 0014
Dr. Stanley Lipshitz Clinic Inc. Terminated
Sandton, Gauteng, South Africa, 2146
Flexivest Fourteen Research Centre Potocnik F C V Recruiting
Durbanville, Western Cape, South Africa, 7500
Ukraine
Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76014
Institute of Neruology, Nat Acad of Med Sci of UKR Recruiting
Kharkiv, Ukraine, 61068
Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str Recruiting
Kharkiv, Ukraine, 61068
Kyiv Regional Medical Incorp. Psychiatria, Center Recruiting
Kyiv, Ukraine, 04080
Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str Recruiting
Kyiv, Ukraine, 8630
Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str. Recruiting
Ternopil', Ukraine, 46027
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. Recruiting
Vinnytsia, Ukraine, 21037
Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology Recruiting
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03575052    
Other Study ID Numbers: ACP-103-046
2017-003536-36 ( EudraCT Number )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: November 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
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Nervous System Diseases
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