Clinical trial NCT03325556: Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Official title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia-related Psychosis
Keywords: 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
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 392
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
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 evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.


Eligibility 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.

Primary outcomes:
measure: Time From Randomization to Relapse in the Double-blind (DB) Period
timeFrame: From randomization in the DB period through 26 weeks
Secondary outcomes:
measure: Time From Randomization to Discontinuation From the DB Period for Any Reason
timeFrame: From randomization in the DB period through 26 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research Inc.
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Aventura
country: United States
facility: Visionary Investigators Network (Aventura Neurologic Associates)
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network (First Choice Neurology Group)
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research Center, LLC
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists LLC
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Winfield
country: United States
facility: Neuroscience Research Institute
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Quincy
country: United States
facility: Alzheimer Disease Center
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Neurology Center of Las Vegas
state: Nevada
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Toms River
country: United States
facility: BioBehavioral Health
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates Ltd.
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Adult Neurology
state: Virginia
city: Russe
country: Bulgaria
facility: Mental Health Center - Ruse EOOD
city: Antofagasta
country: Chile
facility: Psicomed Estudios Medicos
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Médicas L y S
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Praha 10
country: Czechia
facility: Clintrial s.r.o.
city: Praha 10
country: Czechia
facility: AD71, s.r.o.
city: Rychnov nad Kněžnou
country: Czechia
facility: Vestra Clinics, s.r.o
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
city: Toulouse
country: France
facility: Centre de Recherche du Gerontopole - CHU de Toulouse
city: Tuebingen
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova Clinica Neurologica
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisanna
city: Rome
country: Italy
facility: IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
city: Rome
country: Italy
facility: Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
city: Bydgoszcz
country: Poland
facility: Przychodnia Śródmieście Sp. z o.o.
city: Gdańsk
country: Poland
facility: ISPL Wieslaw Jerzy Cubala
city: Katowice
country: Poland
facility: Care Clinic
city: Lublin
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Poznan
country: Poland
facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
city: Siemianowice Śląskie
country: Poland
facility: NEURO-CARE Sp. z o.o. Sp. Komandytowa
city: Szczecin
country: Poland
facility: Euromedis Sp z. o. o.
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Belgrade
country: Serbia
facility: Clinical center of Serbia, Clinic for Neurology
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clinic for Neurology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic-Dedinje
city: Belgrade
country: Serbia
facility: Institut of Mental Health
city: Belgrade
country: Serbia
facility: Psychiatric Clinic, Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinic for Psychiatry, Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
city: Nis
country: Serbia
facility: Clinic for Psychiatry
city: Banska Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
city: Košice
country: Slovakia
facility: Epamed s.r.o., Psychiatricka ambulancia
city: Krompachy
country: Slovakia
facility: NEURES s.r.o. neurologicka ambulancia
city: Svidnik
country: Slovakia
facility: Centrum Zdravia R.B.K., s.r.o.
city: Vranov nad Toplou
country: Slovakia
facility: Crystal Comfort, s.r.o.
city: Barcelona
country: Spain
facility: Clinica IINA
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital General de Cataluña
city: Sevilla
country: Spain
facility: Estudio de Psiquiatría
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Oleksandrivka
country: Ukraine
facility: Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
state: Odessa Region
city: Dnipro
country: Ukraine
facility: Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of Neurology, Psychiatry, and Narcology of the National Academy of Medical Sciences of Ukraine", Department of Clinical, Social, and Paediatric Psychiatry
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional State Clinical Psychiatric Hospital
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
city: Vinnytsya
country: Ukraine
facility: 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
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
city: Bath
country: United Kingdom
facility: Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research - Blackpool
city: London
country: United Kingdom
facility: Re:Cognition Health Ltd.
city: Manchester
country: United Kingdom
facility: MAC Clinical Research - Manchester
Study officials:
References:
citation: 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.
citation: 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.