Clinical trial NCT03575052: A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 784
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: Treatment Period: 8 weeks
Secondary outcomes:
measure: Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
timeFrame: Treatment Period: 8 weeks
measure: Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)
timeFrame: Treatment Period: 8 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Cognitive Clinical Trials
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Hialeah
country: United States
facility: Indago Research & Health Center Inc
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes
state: Florida
city: Miami
country: United States
facility: Future Care Solution, LLC
state: Florida
city: Miami
country: United States
facility: MediClear Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research LLC
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J Mate, MD, PA
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US
state: Florida
city: Newton
country: United States
facility: Boston Center Memory
state: Massachusetts
city: Papillion
country: United States
facility: Cognitive Clinical Trials LLC
state: Nebraska
city: Mount Arlington
country: United States
facility: The NeuroCognitive Institute
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
city: Shaker Heights
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: Central for Biomedical Research, LLC
state: Tennessee
city: Bourgas
country: Bulgaria
facility: Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
city: Pleven
country: Bulgaria
facility: UMHAT Psych clin for gen psychiatry and addictions
city: Sofia
country: Bulgaria
facility: DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre, 2, N. Vaptzarov Street
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd
city: Vratsa
country: Bulgaria
facility: Mental Health Center Vratza EOOD, 1 Belasitsa St
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centr Investigaciones y Proyectos en Neurociencias
state: Atlantico
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental S.A.
state: Risaralda
city: Bogota
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso
city: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Plzen
country: Czechia
facility: A-shine s.r.o./ Lekarna Centrum
city: Praha 10
country: Czechia
facility: AD71, s.r.o.,/Hostivarska Iekarna
city: Praha 5
country: Czechia
facility: Axon Clinical
city: Praha 6
country: Czechia
facility: Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
city: Říčany
country: Czechia
facility: AD71, s.r.o., /,Lekarna DPS Recruiting
city: Tbilisi
country: Georgia
facility: Petre Sarajishvili Institute of Neurology LLC
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem LTD
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic LTD
city: Tbilisi
country: Georgia
facility: Health Institute LLC
city: Tbilisi
country: Georgia
facility: S. Khechinashvili University Hospital LLC
city: Saltillo
country: Mexico
facility: Hospital Universitario Saltillo
state: Coahuila
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Neurologia y Neurocirugia
state: Delegacion Tlalpan
city: Monterrey
country: Mexico
facility: Centro Regional para Adulto Mayor, Hsp Univ, JEG
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Clinicos y Especialidades Medicas
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Christus Muguerza Hospital Sur
state: Nuevo Leon
city: Plewiska
country: Poland
facility: Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych
state: Poznan
city: Bialystok
country: Poland
facility: MlynowaMed SP Psych Dr. Joanna Lazarcyck
city: Białystok
country: Poland
facility: Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski
city: Bydgoszcz
country: Poland
facility: Przychodnia Srodmiescie Sp. z.o.o.
city: Gdańsk
country: Poland
facility: ISPL Wieslaw Jerzy Cubala
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synap
city: Katowice
country: Poland
facility: Silmedic Sp. z.o.o.
city: Kraków
country: Poland
facility: Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
city: Poznań
country: Poland
facility: Centrum Medyczne HCP Sp. z.o.o.
city: Pruszcz Gdański
country: Poland
facility: NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
city: Siemianowice Śląskie
country: Poland
facility: Neuro-Care Sp. z.o.o. sp. Komandytowa
city: Siemianowice Śląskie
country: Poland
facility: Neuro-care
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew, ul. _eromskiego 41A
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
state: Cluj
city: Constanta
country: Romania
facility: Spitalul clinic CF Constanta, Sectia Neurologie
city: Iasi
country: Romania
facility: Med Anima SRL, Clinica de psihiatrie
city: Sibiu
country: Romania
facility: S.C. Carpe Diem SRL
city: Tonnel'nyy
country: Russian Federation
facility: Regional Specialized Psychiatric Hospital #2
state: Kochubeev District
city: Krasnoyarsk
country: Russian Federation
facility: Federal Siberian Sci Clinical Center of Med and Bio
state: Krasnoyarksk Region
city: Tomsk
country: Russian Federation
facility: Clinic "Hundred Years"
state: Tomsk Region
city: Moscow
country: Russian Federation
facility: Mental Health Research Center
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #34
city: Roshchino
country: Russian Federation
facility: Leningrad Regional Psychoneurological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: St. Nicholas the Wonder Worker Psychiatric Hospital
city: Saint Petersburg
country: Russian Federation
facility: FSBI NMRC PN n.a. V.M. Bekhterev
city: Saint Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #3
city: Samara
country: Russian Federation
facility: Samara Psychiatric Hospital
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital V. I. Razumovsky
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Stavropol'
country: Russian Federation
facility: Stavropol Regional Clin Spec Psych Hospital #1
city: Belgrade
country: Serbia
facility: CHC Dr Dragisa Misovic- Dedinje
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic for Psychiatry
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinic for Psychiatric Diseases Dr. Laza Lazarevic
city: Belgrade
country: Serbia
facility: Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Kovin"
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic for Neurology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic of Psychiatry
city: Toponica
country: Serbia
facility: Clinical Center Nis, Clinic for Psychiatry
city: Valjevo
country: Serbia
facility: General Hospital Valjevo, Department for Neurology
city: Pretoria
country: South Africa
facility: Neurology Practice
state: Gauteng
city: Sandton
country: South Africa
facility: Dr. Stanley Lipshitz Clinic Inc.
state: Gauteng
city: Durbanville
country: South Africa
facility: Flexivest Fourteen Research Centre Potocnik F C V
state: Western Cape
city: Dnipro
country: Ukraine
facility: Dnipr Regional Clinical Hospital n.a. Mechnikov
city: Dnipro
country: Ukraine
facility: I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional Rehabilitation Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
city: Kharkiv
country: Ukraine
facility: Institute of Neruology, Nat Acad of Med Sci of UKR
city: Kharkiv
country: Ukraine
facility: Institute of Neurology
city: Kharkiv
country: Ukraine
facility: Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorp. Psychiatria, Center
city: Kyiv
country: Ukraine
facility: Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str
city: Ternopil'
country: Ukraine
facility: Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
city: Vinnytsia
country: Ukraine
facility: 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.
city: Zaporizhzhya
country: Ukraine
facility: Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Reg. Hospital, Neurology Dpt
Study officials:
References: