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Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Primary Purpose

Dementia-related Psychosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Pimavanserin 34 mg
Pimavanserin 20 mg
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia-related Psychosis focused on measuring 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

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ATP Clinical Research Inc.
  • Neurology Center of North Orange County
  • Visionary Investigators Network (Aventura Neurologic Associates)
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • Premier Clinical Research Institute, Inc.
  • Visionary Investigators Network (First Choice Neurology Group)
  • Novel Clinical Research Center, LLC
  • Collier Neurologic Specialists LLC
  • Bioclinica Research
  • Neurology Associates of Ormond Beach
  • Quantum Laboratories
  • Neuroscience Research Institute
  • University of Kansas Medical Center Research Institute, Inc.
  • Alzheimer Disease Center
  • Clinical Research Professionals
  • Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
  • Neurology Center of Las Vegas
  • Memory Enhancement Center of America, Inc.
  • BioBehavioral Health
  • Neurological Associates of Albany, PC
  • Manhattan Behavioral Medicine, PLLC
  • Richmond Behavioral Associates
  • Neuro-Behavioral Clinical Research, Inc.
  • Thomas Jefferson University
  • Abington Neurological Associates Ltd.
  • University of Tennessee Medical Center
  • University of Virginia Adult Neurology
  • Mental Health Center - Ruse EOOD
  • Psicomed Estudios Medicos
  • Biomedica Research Group
  • Especialidades Médicas L y S
  • Fakultni nemocnice Hradec Kralove
  • Clintrial s.r.o.
  • AD71, s.r.o.
  • Vestra Clinics, s.r.o
  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
  • Centre de Recherche du Gerontopole - CHU de Toulouse
  • Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
  • Azienda Ospedaliera di Padova Clinica Neurologica
  • IRCCS San Raffaele Pisanna
  • IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
  • Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
  • Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
  • Przychodnia Śródmieście Sp. z o.o.
  • ISPL Wieslaw Jerzy Cubala
  • Care Clinic
  • Specjalistyczna Praktyka Lekarska
  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Euromedis Sp z. o. o.
  • Centrum Medyczne NeuroProtect
  • Clinical center of Serbia, Clinic for Neurology
  • Military Medical Academy, Clinic for Neurology
  • Clinical Hospital Center Dr Dragisa Misovic-Dedinje
  • Institut of Mental Health
  • Psychiatric Clinic, Military Medical Academy
  • Clinic for Psychiatry, Clinical Center Kragujevac
  • Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
  • Clinic for Psychiatry
  • MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
  • Epamed s.r.o., Psychiatricka ambulancia
  • NEURES s.r.o. neurologicka ambulancia
  • Centrum Zdravia R.B.K., s.r.o.
  • Crystal Comfort, s.r.o.
  • Clinica IINA
  • Hospital Universitari Vall d'Hebron
  • Hospital General de Cataluña
  • Estudio de Psiquiatría
  • Hospital Universitario Virgen del Rocío
  • Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
  • Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
  • 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 Regional Psychiatric Hospital
  • Lviv Regional State Clinical Psychiatric Hospital
  • Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
  • Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
  • 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
  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
  • Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
  • MAC Clinical Research - Blackpool
  • Re:Cognition Health Ltd.
  • MAC Clinical Research - Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Drug - Pimavanserin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2017
Last Updated
May 27, 2021
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03325556
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Drug - Pimavanserin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, tablets, once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Pimavanserin 34 mg
Intervention Description
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Pimavanserin 20 mg
Intervention Description
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Primary Outcome Measure Information:
Title
Time From Randomization to Relapse in the Double-blind (DB) Period
Description
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.
Time Frame
From randomization in the DB period through 26 weeks
Secondary Outcome Measure Information:
Title
Time From Randomization to Discontinuation From the DB Period for Any Reason
Description
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.
Time Frame
From randomization in the DB period through 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for All-cause Dementia according to NIA-AA guidelines 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 Has an MMSE score ≥6 and ≤24 Has had psychotic symptoms for at least 2 months Must be on a stable does of cholinesterase inhibitor or memantine, if applicable 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: Has psychotic symptoms that are primarily attributable to a condition other than dementia Has had a recent major depressive episode Has experienced suicidal ideation or behavior within 3 months prior to study enrollment Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope 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 Had a myocardial infarction within the last 6 months Has a known personal or family history or symptoms of long QT syndrome Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures 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.
Facility Information:
Facility Name
ATP Clinical Research Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Visionary Investigators Network (Aventura Neurologic Associates)
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Visionary Investigators Network (First Choice Neurology Group)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Novel Clinical Research Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Collier Neurologic Specialists LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Quantum Laboratories
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Neuroscience Research Institute
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Alzheimer Disease Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
Neurology Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
BioBehavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Manhattan Behavioral Medicine, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Abington Neurological Associates Ltd.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Virginia Adult Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Mental Health Center - Ruse EOOD
City
Russe
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Psicomed Estudios Medicos
City
Antofagasta
ZIP/Postal Code
1270244
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Especialidades Médicas L y S
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
AD71, s.r.o.
City
Praha 10
ZIP/Postal Code
10900
Country
Czechia
Facility Name
Vestra Clinics, s.r.o
City
Rychnov nad Kněžnou
ZIP/Postal Code
51601
Country
Czechia
Facility Name
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre de Recherche du Gerontopole - CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik für Psychiatrie und Psychotherapie der Universität Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Azienda Ospedaliera di Padova Clinica Neurologica
City
Padova
ZIP/Postal Code
35121
Country
Italy
Facility Name
IRCCS San Raffaele Pisanna
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria
City
Rome
ZIP/Postal Code
00179
Country
Italy
Facility Name
Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA
City
Rome
ZIP/Postal Code
00185
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Przychodnia Śródmieście Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
ISPL Wieslaw Jerzy Cubala
City
Gdańsk
ZIP/Postal Code
80-438
Country
Poland
Facility Name
Care Clinic
City
Katowice
ZIP/Postal Code
40-060
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Euromedis Sp z. o. o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Clinical center of Serbia, Clinic for Neurology
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Military Medical Academy, Clinic for Neurology
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institut of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Psychiatric Clinic, Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Psychiatry, Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
Clinic for Psychiatry
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
Epamed s.r.o., Psychiatricka ambulancia
City
Košice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
NEURES s.r.o. neurologicka ambulancia
City
Krompachy
ZIP/Postal Code
053 42
Country
Slovakia
Facility Name
Centrum Zdravia R.B.K., s.r.o.
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Crystal Comfort, s.r.o.
City
Vranov nad Toplou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Clinica IINA
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General de Cataluña
City
Sant Cugat Del Vallès
ZIP/Postal Code
08195
Country
Spain
Facility Name
Estudio de Psiquiatría
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1
City
Oleksandrivka
State/Province
Odessa Region
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
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
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Lviv Regional State Clinical Psychiatric Hospital
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Facility Name
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
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
MAC Clinical Research - Blackpool
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
Re:Cognition Health Ltd.
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
MAC Clinical Research - Manchester
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34934801
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. Erratum In: Alzheimers Dement (Amst). 2022 Feb 09;14(1):e12290.
Results Reference
derived
PubMed Identifier
34289275
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.
Results Reference
derived
Links:
URL
https://academic.oup.com/innovateage/article/4/Supplement_1/163/6035437
Description
Tariot P, et al. HARMONY study: pimavanserin significantly prolongs time to relapse of dementia-related psychosis. Innov Aging. 2020; 4(suppl 1):163-164.
URL
https://link.springer.com/article/10.14283/jpad.2019.47
Description
Tariot P, et al. HARMONY relapse-prevention study: pimavanserin significantly prolongs time to relapse of dementia-related psychosis. J Prev Alz Dis. 2019; 6(suppl 1):S30-S31

Learn more about this trial

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

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