CClinicalTrials.gg
CompletedNCT03623321Updated Dec 20, 2024Results posted

Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

A Phase 3 interventional study of Pimavanserin in Neuropsychiatric Symptoms Related to Neurodegenerative Disease, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 88 sites in 12 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
595
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

02

Conditions studied

  • Neuropsychiatric Symptoms Related to Neurodegenerative Disease
03

In context

Neurodegenerative Diseases

370 studies on the registry are indexed under Neurodegenerative Diseases; 145 are open to participants now.

This study's enrollment of 595 is above the median of 53 across 204 interventional studies indexed under Neurodegenerative Diseases.

Browse Neurodegenerative Diseases studies →

Lead sponsor

ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject satisfied all entry criteria for the antecedent pimavanserin study
  2. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
  3. Has a designated study partner/caregiver who meets the following requirements:

    1. In the Investigator's opinion, is in contact with the subject frequently enough to accurately report on the subject's symptoms and whether or not the subject is taking the study drug
    2. In the Investigator's opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
    3. Is fluent in the local language in which study assessments will be administered
    4. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
  4. Subject is willing and able to provide informed consent.
  5. 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 during the study and 1 month following completion of the study.

Exclusion criteria

Exclusion Criteria:

  1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
  2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
  3. Has any of the following ECG results at the EOT/ET visit of the antecedent study:

    a. If the subject is not on citalopram, escitalopram, or venlafaxine:

    i. QTcF >450 ms, if QRS duration \<120 ms

    ii. QTcF >470 ms, if QRS duration ≥120 ms

    b. If the subject is on citalopram, escitalopram, or venlafaxine:

    i. QTcF >425 ms, if QRS duration \<120 ms

    ii. QTcF >450 ms, if QRS duration ≥120 ms

  4. Has a heart rate \<50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study.
  5. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:

    1. jeopardize the safe participation of the subject in the study; OR
    2. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
  6. Is suicidal at Visit 1 (Baseline)
  7. Has developed a medical condition that in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
  8. Requires treatment with a medication or other substance that is prohibited by the protocol
  9. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
  10. Is an employee of ACADIA, or has a family member who is an employee of ACADIA

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).

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
595 participants (actual)

Study arms

  • Experimental
    Drug - pimavanserin

    Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.

    Drug: Pimavanserin

Interventions

  • DrugPimavanserin

    • Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.

06

What researchers measure

Primary outcomes

  1. Treatment-emergent Adverse Events (TEAEs)

    Number (%) of patients experiencing at least one TEAE

    Time frame: Treatment period and Follow-up period: 56 weeks

07

Results

Posted Dec 20, 2024

Participant flow

This was an open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in patients with neuropsychiatric symptoms related to neurodegenerative disease, who had completed an antecedent study (ACP-103-046) or had participated in a pimavanserin study that the sponsor terminated early.

Participant flow — Overall Study
MilestonePimavanserin
Started595
Completed452
Not completed143
Withdrew: Adverse event32
Withdrew: Death9
Withdrew: Lack of efficacy9
Withdrew: Lost to follow-up6
Withdrew: Noncompliance with study drug6
Withdrew: Use of prohibited medication3
Withdrew: Physician decision5
Withdrew: Protocol violation1
Withdrew: Consent withdrawn by patient or legally accepted representative29
Withdrew: Not further specified43

Outcome measures

PrimaryTreatment-emergent Adverse Events (TEAEs)

Number (%) of patients experiencing at least one TEAE

Time frame:
Treatment period and Follow-up period: 56 weeks
Reported as:
Count of participants · Participants
Treatment-emergent Adverse Events (TEAEs)
ParticipantsPimavanserin
Treatment-emergent Adverse Events (TEAEs)238

Adverse events

Collected over Treatment period and Follow-up period: 56 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pimavanserin11/595 (1.8%)37/595 (6.2%)0/595 (0%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventPimavanserin
Cerebrovascular accidentNervous system disorders3/595
Cardiac failureCardiac disorders2/595
Cardiac failure congestiveCardiac disorders2/595
PneumoniaInfections and infestations2/595
Femur fractureInjury, poisoning and procedural complications2/595
Brain oedemaNervous system disorders2/595
AgitationPsychiatric disorders2/595
BradycardiaCardiac disorders1/595
Cardiac arrestCardiac disorders1/595
Left ventricular failureCardiac disorders1/595

Baseline characteristics

All patients enrolled and treated

Age, Categorical
Age, Categorical(Participants)Pimavanserin
<=18 years0
Between 18 and 65 years87
>=65 years508
Age, Continuous
Age, Continuous(years)Pimavanserin
Mean72.2 ± 6.69
Sex: Female, Male
Sex: Female, Male(Participants)Pimavanserin
Female348
Male247
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pimavanserin
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American13
White561
More than one race0
Unknown or Not Reported20
Region of Enrollment
Region of Enrollment(participants)Pimavanserin
Colombia16
Romania3
United States197
Czechia30
Ukraine81
Poland90
Mexico9
South Africa11
Georgia25
Bulgaria29
Serbia36
Russia68
Mini Mental State Examination total score
Mini Mental State Examination total score(units on a scale)Pimavanserin
Mean20.0 ± 5.16
08

Study locations

88 sites
  • Cognitive Clinical Trials
    Gilbert, Arizona 85296, United States
  • ATP Clinical Research, Inc.
    Costa Mesa, California 92626, United States
  • Syrentis Clinical Research
    Santa Ana, California 92705, United States
  • Indago Research & Health Center Inc
    Hialeah, Florida 33012, United States
  • Reliable Clinical Research, LLC
    Hialeah, Florida 33012, United States
  • Premier Clinical Research Institute, Inc.
    Miami, Florida 33122, United States
  • Global Medical Institutes
    Miami, Florida 33125, United States
  • Future Care Solution, LLC
    Miami, Florida 33165, United States
  • MediClear Medical & Research Center, Inc.
    Miami, Florida 33165, United States
  • Novel Clinical Research LLC
    Miami, Florida 33186, United States
  • Laszlo J Mate, MD, PA
    North Palm Beach, Florida 33408, United States
  • Synexus Clinical Research US, Inc.
    The Villages, Florida 32162, United States
  • The NeuroCognitive Institute
    Mount Arlington, New Jersey 07856, United States
  • UNC Hospital
    Chapel Hill, North Carolina 27599, United States
  • Insight Clinical Trials LLC
    Shaker Heights, Ohio 44122, United States
  • Suburban Research Associates
    Media, Pennsylvania 19063, United States
  • Central for Biomedical Research, LLC
    Knoxville, Tennessee 37909, United States
  • Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
    Bourgas, 8000, Bulgaria
  • UMHAT Psych clin for gen psychiatry and addictions
    Pleven, 5800, Bulgaria
  • DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
    Sofia, 1408, Bulgaria
  • Diagnostic Consultative Centre, 2, N. Vaptzarov Street
    Varna, 9000, Bulgaria
  • Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.
    Varna, 9000, Bulgaria
  • Mental Health Center Vratza EOOD, 1 Belasitsa St.
    Vratsa, 3000, Bulgaria
  • E.S.E. Hospital Mental de Antioquia
    Bello, Antioquia, 051053, Colombia
  • Centr Investigaciones y Proyectos en Neurociencias
    Barranquilla, Atlántico 080020, Colombia
  • Psynapsis Salud Mental S.A.
    Pereira, Risaralda 66001, Colombia
  • Centro de Investigaciones del Sistema Nervioso
    Bogotá, 111166, Colombia
  • BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113
    Kladno, 27204, Czechia
  • A-shine s.r.o./ Lekarna Centrum
    Plzen, 31200, Czechia
  • Axon Clinical
    Praha 5, 1500, Czechia
  • Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
    Praha 6, 16010, Czechia
  • AD71, s.r.o./Hostivarska lekarna
    Praha, 10200, Czechia
  • Petre Sarajishvili Institute of Neurology LLC
    Tbilisi, 0112, Georgia
  • Pineo Medical Ecosystem LTD
    Tbilisi, 0114, Georgia
  • Tbilisi Heart and Vascular Clinic LTD
    Tbilisi, 0159, Georgia
  • Health Institute LLC
    Tbilisi, 0160, Georgia
  • S. Khechinashvili University Hospital LLC
    Tbilisi, 0179, Georgia
  • Hospital Universitario Saltillo
    Saltillo, Coahuila 25000, Mexico
  • Clinicos y Especialidades Medicas
    Monterrey, Nuevo Leon 64620, Mexico
  • Christus Muguerza Hospital Sur
    Monterrey, Nuevo Leon 64988, Mexico
  • MlynowaMed Sp Psych Dr. Joanna Lazarczyk
    Białystok, 15-404, Poland
  • Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski
    Białystok, 15-464, Poland
  • Przychodnia Srodmiescie Sp. z.o.o.
    Bydgoszcz, 85-080, Poland
  • ISPL Wieslaw Jerzy Cubala
    Gdańsk, 80-438, Poland
  • NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
    Gdańsk, 83-000, Poland
  • Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
    Kraków, 31-505, Poland
  • Centrum Medyczne HCP Sp. zo.o
    Poznań, 61-485, Poland
  • Neuro-Care Sp. zo.o. sp. Komandytowa
    Siemianowice Śląskie, 41-100, Poland
  • Neuro-care
    Siemianowice Śląskie, 41-100, Poland
  • RCMed Oddzial Sochaczew, ul. _eromskiego 41A
    Sochaczew, 96-500, Poland
  • Spitalul clinic CF Constanta, Sectia Neurologie
    Constanta, 900123, Romania
  • Med Anima SRL, Clinica de psihiatrie
    Iasi, 700004, Romania
  • S.C. Carpe Diem SRL
    Sibiu, 550281, Romania
  • Regional Specialized Psychiatric Hospital #2
    Tonnel'nyy, Kochubeev District 357034, Russian Federation
  • Federal Siberian Sci Clinical Center of Med and Bio
    Krasnoyarsk, 660037, Russian Federation
  • Mental Health Research Center
    Moscow, 115522, Russian Federation
  • City Clinical Hospital #34
    Novosibirsk, 630054, Russian Federation
  • Leningrad Regional Psychoneurological Dispensary
    Roshchino, 188820, Russian Federation
  • St. Nicholas the Wonder Worker Psychiatric Hospital
    Saint Petersburg, 190121, Russian Federation
  • FSBI NMRC PN n.a. V.M. Bekhterev
    Saint Petersburg, 1931167, Russian Federation
  • Samara Psychiatric Hospital
    Samara, 443016, Russian Federation
  • Saratov City Clinical Hospital V. I. Razumovsky
    Saratov, 410028, Russian Federation
  • Stavropol Regional Clin Spec Psych Hospital #1
    Stavropol', 355038, Russian Federation
  • Clinic "Hundred Years"
    Tomsk, 634009, Russian Federation
  • CHC Dr Dragisa Misovic- Dedinje
    Belgrade, 11000, Serbia
  • Clinical Center of Serbia, Clinic for Psychiatry
    Belgrade, 11000, Serbia
  • Clinical Center of Serbia,Clinic for Neurology
    Belgrade, 11000, Serbia
  • Military Medical Academy
    Belgrade, 11000, Serbia
  • Clinic for Psychiatric Diseases Dr. Laza Lazarevic
    Belgrade, 18000, Serbia
  • Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
    Belgrade, 34000, Serbia
  • Special Hospital for Psychiatric Diseases "Kovin"
    Kovin, 26220, Serbia
  • Clinical Center Kragujevac, Clinic for Neurology
    Kragujevac, 34000, Serbia
  • Clinical Center Kragujevac,Clinic of Psychiatry
    Kragujevac, 34000, Serbia
  • Clinical Center Nis, Clinic for Psychiatry
    Toponica, 18202, Serbia
  • General Hospital Valjevo, Department for Neurology
    Valjevo, 14000, Serbia
  • Neurology Practice
    Pretoria, Gauteng 0014, South Africa
  • Flexivest Fourteen Research Centre Potocnik F C V
    Durban, Western Cape 7500, South Africa
  • Dnipropetrovsk Regional Rehabilitation Hospital
    Dnipro, 49000, Ukraine
  • Dnir. Regional Clinical Hospital n.a. Mechnikov
    Dnipro, 49005, Ukraine
  • Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
    Ivano-Frankivs'k, 76014, Ukraine
  • Institute of Neruology, Nat Acad of Med Sci of UKR
    Kharkiv, 61068, Ukraine
  • Institute of Neurology
    Kharkiv, 61068, Ukraine
  • Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str.
    Kharkiv, 61068, Ukraine
  • Kyiv Regional Medical Incorp. Psychiatria, Center
    Kyiv, 04080, Ukraine
  • Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha
    Kyiv, 8630, Ukraine
  • Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
    Ternopil', 46027, Ukraine
  • 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, Department of Psychiatry, Narcology and Psychotherapeutics
    Vinnytsia, 21037, Ukraine
  • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
    Zaporizhzhya, 69600, Ukraine
09

References and documents

Study documents

  • Study protocol · Mar 5, 2021
  • Statistical analysis plan · Mar 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03623321
Lead sponsor
ACADIA Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Aug 9, 2018
Start date
Jul 17, 2018
Primary completion
May 5, 2023
Completion
May 5, 2023
Results posted
Dec 20, 2024
Last update
Dec 20, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion