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Dementia-related PsychosisPhase 3NCT03325556

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

A Phase 3 study testing Pimavanserin 34 mg and Pimavanserin 20 mg in people with Dementia-related Psychosis, run by ACADIA Pharmaceuticals Inc. at 83 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Dementia-related Psychosis
What is being tested?
Pimavanserin 34 mg and Pimavanserin 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
83 sitesin 13 countries
Study dates
27 Sep 2017to 30 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

United States27 sites

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Visionary Investigators Network (Aventura Neurologic Associates)

    Aventura, Florida, 33180

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • University of Virginia Adult Neurology

    Charlottesville, Virginia, 22903

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • ATP Clinical Research Inc.

    Costa Mesa, California, 92626

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Neurology Center of Las Vegas

    Las Vegas, Nevada, 89128

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Visionary Investigators Network (First Choice Neurology Group)

    Miami, Florida, 33176

  • Novel Clinical Research Center, LLC

    Miami, Florida, 33186

  • Collier Neurologic Specialists LLC

    Naples, Florida, 34102

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10036

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720

  • Bioclinica Research

    Orlando, Florida, 32806

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Alzheimer Disease Center

    Quincy, Massachusetts, 02169

  • Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research

    St Louis, Missouri, 63132

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • BioBehavioral Health

    Toms River, New Jersey, 08755

  • Abington Neurological Associates Ltd.

    Willow Grove, Pennsylvania, 19090

  • Neuroscience Research Institute

    Winfield, Illinois, 60190

Other trials in United States

Ukraine10 sites

  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"

    Dnipro, 49005

  • Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"

    Kharkiv, 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

    Kharkiv, 61068

  • Kherson Regional Psychiatric Hospital

    Kherson, 73488

  • Lviv Regional State Clinical Psychiatric Hospital

    Lviv, 79021

  • Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18

    Odesa, 65006

  • Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1

    Oleksandrivka, Odesa Oblast, 67513

  • Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev

    Poltava, 36013

  • 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

    Vinnytsia, 21005

  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"

    Zaporizhzhya, 69600

Other trials in Ukraine

Poland8 sites

  • Przychodnia Śródmieście Sp. z o.o.

    Bydgoszcz, 85-080

  • ISPL Wieslaw Jerzy Cubala

    Gdansk, 80-438

  • Care Clinic

    Katowice, 40-060

  • Specjalistyczna Praktyka Lekarska

    Lublin, 20-582

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

    Poznan, 61-853

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Siemianowice Śląskie, 41-100

  • Euromedis Sp z. o. o.

    Szczecin, 70-111

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-697

Other trials in Poland

Serbia8 sites

  • Clinical center of Serbia, Clinic for Neurology

    Belgrade, 11 000

  • Military Medical Academy, Clinic for Neurology

    Belgrade, 11 000

  • Clinical Hospital Center Dr Dragisa Misovic-Dedinje

    Belgrade, 11000

  • Institut of Mental Health

    Belgrade, 11000

  • Psychiatric Clinic, Military Medical Academy

    Belgrade, 11000

  • Clinic for Psychiatry, Clinical Center Kragujevac

    Kragujevac, 34 000

  • Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac

    Kragujevac, 34 000

  • Clinic for Psychiatry

    Niš, 18 000

Other trials in Serbia

Italy5 sites

  • Azienda Ospedaliera di Padova Clinica Neurologica

    Padova, 35121

  • IRCCS San Raffaele Pisanna

    Rome, 00163

  • IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria

    Rome, 00179

  • Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA

    Rome, 00185

  • Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I

    Torino, 10126

Other trials in Italy

Slovakia5 sites

  • MUDr. Beata Dupejova, neurologicka ambulancia s.r.o

    Banská Bystrica, 974 04

  • Epamed s.r.o., Psychiatricka ambulancia

    Košice, 040 01

  • NEURES s.r.o. neurologicka ambulancia

    Krompachy, 053 42

  • Centrum Zdravia R.B.K., s.r.o.

    Svidník, 089 01

  • Crystal Comfort, s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Spain5 sites

  • Clinica IINA

    Barcelona, 08006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital General de Cataluña

    Sant Cugat del Vallès, 08195

  • Estudio de Psiquiatría

    Seville, 41003

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

Czechia4 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Clintrial s.r.o.

    Prague, 10000

  • AD71, s.r.o.

    Prague, 10900

  • Vestra Clinics, s.r.o

    Rychnov nad Kněžnou, 51601

Other trials in Czechia

United Kingdom4 sites

  • Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre

    Bath, BA1 3NG

  • MAC Clinical Research - Blackpool

    Blackpool, FY2 0JH

  • Re:Cognition Health Ltd.

    London, W1G 9JF

  • MAC Clinical Research - Manchester

    Manchester, M13 9NQ

Other trials in United Kingdom

Chile3 sites

  • Psicomed Estudios Medicos

    Antofagasta, 1270244

  • Biomedica Research Group

    Santiago, 7500710

  • Especialidades Médicas L y S

    Santiago, 7560356

Other trials in Chile

France2 sites

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay

    Marseille, 13385

  • Centre de Recherche du Gerontopole - CHU de Toulouse

    Toulouse, 31059

Other trials in France

Bulgaria1 site

  • Mental Health Center - Ruse EOOD

    Rousse, 7003

Other trials in Bulgaria

Germany1 site

  • Klinik für Psychiatrie und Psychotherapie der Universität Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: 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.

Being tested
Placebo, Pimavanserin 34 mg, Pimavanserin 20 mg
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
Medical subject headings
Dementia, Lewy Body Disease, Alzheimer Disease, Supranuclear Palsy, Progressive, Corticobasal Degeneration, Dementia, Vascular, Hallucinations, Delusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo, tablets, once daily by mouth

  • Pimavanserin 34 mgDrug

    Pimavanserin 34 mg total daily dose, tablets, once daily by mouth

  • Pimavanserin 20 mgDrug

    Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Study groups in NCT03325556
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Drug - PimavanserinExperimentalNot described
Receives: Drug: Pimavanserin 34 mg; Drug: Pimavanserin 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization in the DB period through 26 weeks

Secondary outcomes (1)

  1. 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.

    Measured: From randomization in the DB period through 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start27 Sep 2017
  3. Primary completion31 Jul 2019
  4. Study completion30 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325556
Sponsor's protocol ID
ACP-103-045
Other IDs
2017-002227-13, 2017
Status last verified
May 2021
First submitted
18 Oct 2017
Last updated
21 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Torres-Yaghi Y, Chrones L, Abler V, Brunson G. Safety and efficacy of pimavanserin in patients with Lewy body dementia experiencing dementia-related psychosis in the HARMONY study. BMC Neurol. 2025 Nov 24;25(1):479. doi: 10.1186/s12883-025-04496-8.

    PubMed 41286676

  • 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.

    PubMed 34934801

  • 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.

    PubMed 34289275

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin 34 mg and Pimavanserin 20 mg in people with Dementia-related Psychosis, run by ACADIA Pharmaceuticals Inc. at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Ukraine, Poland, Serbia, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Relapse in the Double-blind (DB) Period (time frame: From randomization in the DB period through 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325556, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.

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