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Neuropsychiatric Symptoms Related to Neurodegenerative DiseasePhase 3NCT03575052

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

A Phase 3 study testing Pimavanserin in people with Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by ACADIA Pharmaceuticals Inc. at 104 sites in 12 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 assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Pimavanserin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
784 participants
Where
104 sitesin 12 countries
Study dates
21 May 2018to 6 May 2022
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
  • The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
  • The subject must provide written (if capable) informed assent
  • Subject requires some or complete assistance with one or more of the following:
  • Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
  • Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
Show all 19Show fewer
  • Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):
  • Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
  • Dementia with Lewy bodies (DLB)
  • All-cause dementia, possible or probable Alzheimer's disease (AD)
  • Frontotemporal degeneration spectrum disorders, including possible or probable:
  • Behavioral variant frontotemporal dementia
  • Progressive supranuclear palsy
  • Corticobasal degeneration
  • Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)
  • Has a designated study partner/caregiver
  • Can come to the clinic for study visits with a study partner/caregiver
  • If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent.
  • If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)

Who cannot join

  • Is in hospice, is receiving end-of-life palliative care, or is bedridden
  • Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
  • Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
  • Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
  • Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:
  • intracranial mass lesion
Show all 11Show fewer
  • vascular malformation
  • evidence of >4 hemosiderin deposits
  • The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor.
  • Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
  • Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Trial locations and contacts

104 sites in 12 countries.

104 sites in 12 countries

United States21 sites

  • UNC Hospital

    Chapel Hill, North Carolina, 27599

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Cognitive Clinical Trials

    Gilbert, Arizona, 85296

  • Indago Research & Health Center Inc

    Hialeah, Florida, 33012

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012

  • Central for Biomedical Research, LLC

    Knoxville, Tennessee, 37909

  • Axcess Medical Research

    Loxahatchee Groves, Florida, 33470

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Global Medical Institutes

    Miami, Florida, 33125

  • Future Care Solution, LLC

    Miami, Florida, 33165

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165

  • Novel Clinical Research LLC

    Miami, Florida, 33186

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Boston Center Memory

    Newton, Massachusetts, 02459

  • Laszlo J Mate, MD, PA

    North Palm Beach, Florida, 33408

  • Cognitive Clinical Trials LLC

    Papillion, Nebraska, 68046

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Insight Clinical Trials LLC

    Shaker Heights, Ohio, 44122

  • University of South Florida

    Tampa, Florida, 33613

  • Synexus Clinical Research US

    The Villages, Florida, 32162

Other trials in United States

Poland13 sites

  • MlynowaMed SP Psych Dr. Joanna Lazarcyck

    Bialystok, 15-404

  • Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski

    Bialystok, 15-464

  • Przychodnia Srodmiescie Sp. z.o.o.

    Bydgoszcz, 85-080

  • ISPL Wieslaw Jerzy Cubala

    Gdansk, 80-438

  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synap

    Katowice, 40-123

  • Silmedic Sp. z.o.o.

    Katowice, 40-282

  • Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3

    Krakow, 31-505

  • Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych

    Plewiska, Poznan, 62-064

  • Centrum Medyczne HCP Sp. z.o.o.

    Poznan, 61-485

  • NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz

    Pruszcz Gdański, 83-000

  • Neuro-Care Sp. z.o.o. sp. Komandytowa

    Siemianowice Śląskie, 41-100

  • Neuro-care

    Siemianowice Śląskie, 41-100

  • RCMed Oddzial Sochaczew, ul. _eromskiego 41A

    Sochaczew, 96-500

Other trials in Poland

Russia13 sites

  • Federal Siberian Sci Clinical Center of Med and Bio

    Krasnoyarsk, Krasnoyarksk Region, 660037

  • Mental Health Research Center

    Moscow, 115522

  • City Clinical Hospital #34

    Novosibirsk, 630054

  • Leningrad Regional Psychoneurological Dispensary

    Roshchino, 188820

  • St. Nicholas the Wonder Worker Psychiatric Hospital

    Saint Petersburg, 190121

  • FSBI NMRC PN n.a. V.M. Bekhterev

    Saint Petersburg, 193167

  • City Psychiatric Hospital #3

    Saint Petersburg, 197341

  • Samara Psychiatric Hospital

    Samara, 443016

  • Saratov City Clinical Hospital V. I. Razumovsky

    Saratov, 410028

  • Smolensk State Medical University

    Smolensk, 214019

  • Stavropol Regional Clin Spec Psych Hospital #1

    Stavropol, 355038

  • Clinic "Hundred Years"

    Tomsk, Tomsk Oblast, 634009

  • Regional Specialized Psychiatric Hospital #2

    Tonnel'nyy, Kochubeev District, 357034

Other trials in Russia

Ukraine13 sites

  • Dnipr Regional Clinical Hospital n.a. Mechnikov

    Dnipro, 49005

  • I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49005

  • Dnipropetrovsk Regional Rehabilitation Hospital

    Dnipro, 49128

  • Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital

    Ivano-Frankivsk, 76014

  • Institute of Neruology, Nat Acad of Med Sci of UKR

    Kharkiv, 61068

  • Institute of Neurology

    Kharkiv, 61068

  • Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str

    Kharkiv, 61068

  • Kyiv Regional Medical Incorp. Psychiatria, Center

    Kyiv, 04080

  • Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str

    Kyiv, 8630

  • Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.

    Ternopil, 46027

  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #7, Female Department #10, Vinnytsya, National Medical University n.a. M.I.Pyrogov, 109 Pyrogova str.

    Vinnytsia, 21037

  • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

    Zaporizhzhya, 69600

  • Zaporizhzhya Reg. Hospital, Neurology Dpt

    Zaporizhzhya, 69600

Other trials in Ukraine

Serbia10 sites

  • CHC Dr Dragisa Misovic- Dedinje

    Belgrade, 11000

  • Clinical Center of Serbia, Clinic for Psychiatry

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinic for Psychiatric Diseases Dr. Laza Lazarevic

    Belgrade, 18000

  • Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

    Belgrade, 34000

  • Special Hospital for Psychiatric Diseases "Kovin"

    Kovin, 26220

  • Clinical Center Kragujevac, Clinic for Neurology

    Kragujevac, 34000

  • Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac, 34000

  • Clinical Center Nis, Clinic for Psychiatry

    Toponica, 18202

  • General Hospital Valjevo, Department for Neurology

    Valjevo, 14000

Other trials in Serbia

Czechia7 sites

  • BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113

    Kladno, 27204

  • Fakultni nemocnice Olomouc

    Olomouc, 77900

  • A-shine s.r.o./ Lekarna Centrum

    Pilsen, 31200

  • AD71, s.r.o.,/Hostivarska Iekarna

    Prague, 10200

  • Axon Clinical

    Prague, 1500

  • Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1

    Prague, 16010

  • AD71, s.r.o., /,Lekarna DPS Recruiting

    Říčany, 25101

Other trials in Czechia

Bulgaria6 sites

  • Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero

    Burgas, 8000

  • UMHAT Psych clin for gen psychiatry and addictions

    Pleven, 5800

  • DCC Sv. Vrach and Sv. Sv. Kozma and Damyan

    Sofia, 1408

  • Diagnostic Consultative Centre, 2, N. Vaptzarov Street

    Varna, 9000

  • Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd

    Varna, 9000

  • Mental Health Center Vratza EOOD, 1 Belasitsa St

    Vratsa, 3000

Other trials in Bulgaria

Georgia5 sites

  • Petre Sarajishvili Institute of Neurology LLC

    Tbilisi, 0112

  • Pineo Medical Ecosystem LTD

    Tbilisi, 0114

  • Tbilisi Heart and Vascular Clinic LTD

    Tbilisi, 0159

  • Health Institute LLC

    Tbilisi, 0160

  • S. Khechinashvili University Hospital LLC

    Tbilisi, 0179

Other trials in Georgia

Mexico5 sites

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, Delegacion Tlalpan, 14269

  • Centro Regional para Adulto Mayor, Hsp Univ, JEG

    Monterrey, Nuevo León, 64460

  • Clinicos y Especialidades Medicas

    Monterrey, Nuevo León, 64620

  • Christus Muguerza Hospital Sur

    Monterrey, Nuevo León, 64988

  • Hospital Universitario Saltillo

    Saltillo, Coahuila, 25000

Other trials in Mexico

Colombia4 sites

  • Centr Investigaciones y Proyectos en Neurociencias

    Barranquilla, Atlántico, 080020

  • E.S.E. Hospital Mental de Antioquia

    Bello, Antioquia, 51053

  • Centro de Investigaciones del Sistema Nervioso

    Bogotá, 111166

  • Psynapsis Salud Mental S.A.

    Pereira, Risaralda Department, 66001

Other trials in Colombia

Romania4 sites

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, Cluj, 400012

  • Spitalul clinic CF Constanta, Sectia Neurologie

    Constanța, 900123

  • Med Anima SRL, Clinica de psihiatrie

    Iași, 700004

  • S.C. Carpe Diem SRL

    Sibiu, 550281

Other trials in Romania

South Africa3 sites

  • Flexivest Fourteen Research Centre Potocnik F C V

    Durbanville, Western Cape, 7500

  • Neurology Practice

    Pretoria, Gauteng, 0014

  • Dr. Stanley Lipshitz Clinic Inc.

    Sandton, Gauteng, 2146

Other trials in South Africa

About this study

Official title: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

Being tested
Pimavanserin, Placebo

What participants receive

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

  • PimavanserinDrug

    Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

  • PlaceboDrug

    Placebo, tablets, once daily by mouth (provided as two placebo tablets)

Study groups in NCT03575052
Study groupRoleWhat they receive
Drug - PimavanserinExperimentalNot described
Receives: Drug: Pimavanserin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Treatment-emergent Adverse Events (TEAEs)

    Number (%) of patients with treatment-emergent AEs

    Measured: Treatment Period: 8 weeks

Secondary outcomes (2)

  1. Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)

    The ESRS is a questionnaire to assess drug induced movement disorders, including parkinsonism; the ESRS-A is an accepted modified form of the original ESRS. The ESRS-A consists of 4 subscales and 4 clinical global impression movement severity scales of Parkinsonism, dyskinesia, dystonia, and akathisia. The Parkinsonism scale consists of 10 items, the dyskinesia subscale of 6 items, the dystonia subscale of 6 items, and the akathisia subscale of 2 items. Each item is scored on a 6-point scale from 0 (absent) to 5 (extreme). The ESRS-A total score is the sum of the 24 item scores with a possible range of 0 to 120. Higher scores denote more severe drug-induced movement disorders.

    Measured: Treatment Period: 8 weeks

  2. Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)

    The MMSE is a 30-item questionnaire to quantitatively assess cognition, focusing on questions related to time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying a drawing. Each of the 30 items has 2 possible values of 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the 30 item scores; thus, it can range from 0 to 30. Lower scores indicate more severe cognitive impairment.

    Measured: Treatment Period: 8 weeks

Timeline

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

  1. First posted2 Jul 2018
  2. Study start21 May 2018
  3. Primary completion6 May 2022
  4. Study completion6 May 2022

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
784 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575052
Sponsor's protocol ID
ACP-103-046
Other IDs
2017-003536-36, 2017
Status last verified
Dec 2024
First submitted
9 Jun 2018
Last updated
31 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alva G, Cubala WJ, Berrio A, Coate B, Abler V, Pathak S. Safety Profile of Pimavanserin Therapy in Elderly Patients with Neurodegenerative Disease-Related Neuropsychiatric Symptoms: A Phase 3B Study. J Alzheimers Dis. 2024;98(1):265-274. doi: 10.3233/JAD-231167.

    PubMed 38427485

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin in people with Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by ACADIA Pharmaceuticals Inc. at 104 sites in 12 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 19 inclusion and 11 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Poland, Russia, Ukraine, Serbia and 7 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 31 Dec 2024). 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?

Treatment-emergent Adverse Events (TEAEs) (time frame: Treatment Period: 8 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 NCT03575052, which also lists 1 linked publication.

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 31 Dec 2024.

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