Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

May 27, 2021 updated by: ACADIA Pharmaceuticals Inc.

A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Russe, Bulgaria, 7003
        • Mental Health Center - Ruse EOOD
  • Chile
      • Antofagasta, Chile, 1270244
        • Psicomed Estudios Medicos
      • Santiago, Chile, 7500710
        • Biomedica Research Group
      • Santiago, Chile, 7560356
        • Especialidades Medicas L Y S
  • Czechia
      • Hradec Králové, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Praha 10, Czechia, 10000
        • CLINTRIAL s.r.o.
      • Praha 10, Czechia, 10900
        • AD71, s.r.o.
      • Rychnov nad Kněžnou, Czechia, 51601
        • Vestra Clinics, s.r.o
  • France
      • Marseille, France, 13385
        • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
      • Toulouse, France, 31059
        • Centre de Recherche du Gerontopole - CHU de Toulouse
  • Germany
      • Tuebingen, Germany, 72076
        • Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
  • Italy
      • Padova, Italy, 35121
        • Azienda Ospedaliera di Padova Clinica Neurologica
      • Rome, Italy, 00163
        • IRCCS San Raffaele Pisanna
      • Rome, Italy, 00179
        • IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
      • Rome, Italy, 00185
        • Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
  • Poland
      • Bydgoszcz, Poland, 85-080
        • Przychodnia Srodmiescie SP. z o.o.
      • Gdańsk, Poland, 80-438
        • ISPL Wieslaw Jerzy Cubala
      • Katowice, Poland, 40-060
        • CaRe Clinic
      • Lublin, Poland, 20-582
        • Specjalistyczna Praktyka Lekarska
      • Poznan, Poland, 61-853
        • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
      • Siemianowice Śląskie, Poland, 41-100
        • NEURO-CARE Sp. z o.o. Sp. Komandytowa
      • Szczecin, Poland, 70-111
        • Euromedis Sp z. o. o.
      • Warszawa, Poland, 01-697
        • Centrum Medyczne NeuroProtect
  • Serbia
      • Belgrade, Serbia, 11 000
        • Clinical center of Serbia, Clinic for Neurology
      • Belgrade, Serbia, 11 000
        • Military Medical Academy, Clinic for Neurology
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Dr Dragisa Misovic-Dedinje
      • Belgrade, Serbia, 11000
        • Institut of Mental Health
      • Belgrade, Serbia, 11000
        • Psychiatric Clinic, Military Medical Academy
      • Kragujevac, Serbia, 34 000
        • Clinic for Psychiatry, Clinical Center Kragujevac
      • Kragujevac, Serbia, 34 000
        • Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
      • Nis, Serbia, 18 000
        • Clinic for Psychiatry
  • Slovakia
      • Banska Bystrica, Slovakia, 974 04
        • MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
      • Košice, Slovakia, 040 01
        • Epamed s.r.o., Psychiatricka ambulancia
      • Krompachy, Slovakia, 053 42
        • NEURES s.r.o. neurologicka ambulancia
      • Svidnik, Slovakia, 089 01
        • Centrum Zdravia R.B.K., s.r.o.
      • Vranov nad Toplou, Slovakia, 093 01
        • Crystal Comfort, s.r.o.
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08006
        • Clinica IINA
      • Sant Cugat Del Vallès, Spain, 08195
        • Hospital General de Cataluña
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41003
        • Estudio de Psiquiatría
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
      • Kharkiv, Ukraine, 61068
        • Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
      • Kharkiv, Ukraine, 61068
        • State Institution "Institute of Neurology, Psychiatry, and Narcology of the National Academy of Medical Sciences of Ukraine", Department of Clinical, Social, and Paediatric Psychiatry
      • Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
      • Lviv, Ukraine, 79021
        • Lviv Regional State Clinical Psychiatric Hospital
      • Odesa, Ukraine, 65006
        • Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
      • Poltava, Ukraine, 36013
        • Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
      • Vinnytsya, Ukraine, 21005
        • 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
      • Zaporizhzhya, Ukraine, 69600
        • Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
    • Odessa Region
      • Oleksandrivka, Odessa Region, Ukraine, 67513
        • Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
      • Blackpool, United Kingdom, FY2 0JH
        • MAC Clinical Research - Blackpool
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health Ltd.
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research - Manchester
  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research Inc.
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network (Aventura Neurologic Associates)
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Miami, Florida, United States, 33122
        • Premier Clinical Research Institute, Inc.
      • Miami, Florida, United States, 33176
        • Visionary Investigators Network (First Choice Neurology Group)
      • Miami, Florida, United States, 33186
        • Novel Clinical Research Center, LLC
      • Naples, Florida, United States, 34102
        • Collier Neurologic Specialists LLC
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Neuroscience Research Institute
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Alzheimer Disease Center
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Saint Louis, Missouri, United States, 63132
        • Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Neurology Center of Las Vegas
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc.
      • Toms River, New Jersey, United States, 08755
        • BioBehavioral Health
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, PC
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine, PLLC
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Neuro-Behavioral Clinical Research, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates LTD.
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Adult Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Placebo Comparator: Placebo
Drug: Placebo
Placebo, tablets, once daily by mouth
Experimental: Drug - Pimavanserin
Drug: Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Drug: Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomization to Relapse in the Double-blind (DB) Period
Time Frame: From randomization in the DB period through 26 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomization to Discontinuation From the DB Period for Any Reason
Time Frame: From randomization in the DB period through 26 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACADIA Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-103-045
  • 2017-002227-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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