Dementia-related Psychosis Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
| Verified date | May 2021 |
| Source | ACADIA Pharmaceuticals Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 392 |
| Est. completion date | October 30, 2019 |
| Est. primary completion date | July 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 90 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Mental Health Center - Ruse EOOD | Russe | |
| Chile | Psicomed Estudios Medicos | Antofagasta | |
| Chile | Biomedica Research Group | Santiago | |
| Chile | Especialidades Médicas L y S | Santiago | |
| Czechia | Fakultni nemocnice Hradec Kralove | Hradec Králové | |
| Czechia | AD71, s.r.o. | Praha 10 | |
| Czechia | Clintrial s.r.o. | Praha 10 | |
| Czechia | Vestra Clinics, s.r.o | Rychnov nad Knežnou | |
| France | 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 | |
| Germany | Klinik für Psychiatrie und Psychotherapie der Universität Tübingen | Tuebingen | |
| Italy | Azienda Ospedaliera di Padova Clinica Neurologica | Padova | |
| Italy | IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria | Rome | |
| Italy | IRCCS San Raffaele Pisanna | 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 | |
| Poland | Przychodnia Sródmiescie 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 Spólka Partnerska Lekarzy | Poznan | |
| Poland | NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice Slaskie | |
| Poland | Euromedis Sp z. o. o. | Szczecin | |
| Poland | Centrum Medyczne NeuroProtect | Warszawa | |
| Serbia | Clinical center of Serbia, Clinic for Neurology | Belgrade | |
| Serbia | Clinical Hospital Center Dr Dragisa Misovic-Dedinje | Belgrade | |
| Serbia | Institut of Mental Health | Belgrade | |
| Serbia | Military Medical Academy, Clinic for Neurology | 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 | Nis | |
| Slovakia | MUDr. Beata Dupejova, neurologicka ambulancia s.r.o | Banska 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. | Svidnik | |
| Slovakia | Crystal Comfort, s.r.o. | Vranov nad Toplou | |
| Spain | Clinica IINA | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital General de Cataluña | Sant Cugat Del Vallès | |
| Spain | Estudio de Psiquiatría | Sevilla | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| 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 | Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1 | Oleksandrivka | Odessa Region |
| 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 | Vinnytsya | |
| Ukraine | Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council" | Zaporizhzhya | |
| United Kingdom | 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 States | Neurological Associates of Albany, PC | Albany | New York |
| 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 | University of Virginia Adult Neurology | Charlottesville | Virginia |
| United States | Clinical Research Professionals | Chesterfield | Missouri |
| United States | ATP Clinical Research Inc. | Costa Mesa | California |
| United States | Memory Enhancement Center of America, Inc. | Eatontown | New Jersey |
| United States | Neurology Center of North Orange County | Fullerton | California |
| United States | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | Neurology Center of Las Vegas | Las Vegas | Nevada |
| United States | Novel Clinical Research Center, LLC | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. | Miami | Florida |
| United States | Visionary Investigators Network (First Choice Neurology Group) | Miami | Florida |
| United States | Collier Neurologic Specialists LLC | Naples | Florida |
| United States | Manhattan Behavioral Medicine, PLLC | New York | New York |
| United States | Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio |
| United States | Bioclinica Research | Orlando | Florida |
| United States | Neurology Associates of Ormond Beach | Ormond Beach | Florida |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Quantum Laboratories | Pompano Beach | Florida |
| United States | Alzheimer Disease Center | Quincy | Massachusetts |
| United States | Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research | Saint Louis | Missouri |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | BioBehavioral Health | Toms River | New Jersey |
| United States | Abington Neurological Associates Ltd. | Willow Grove | Pennsylvania |
| United States | Neuroscience Research Institute | Winfield | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| ACADIA Pharmaceuticals Inc. |
United States, Bulgaria, Chile, Czechia, France, Germany, Italy, Poland, Serbia, Slovakia, Spain, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time From Randomization to Relapse in the Double-blind (DB) Period | The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR).
Relapse was defined as (1) =30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score =6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis. SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy. |
From randomization in the DB period through 26 weeks | |
| Secondary | Time From Randomization to Discontinuation From the DB Period for Any Reason | The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR. | From randomization in the DB period through 26 weeks |