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

NCT03575052 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: ACP-103-0462017-003536-36
• Study Type: interventional
• Target: 784
• Locations: 12 countries
• Sites: 104

Brief 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.

Conditions

Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events (TEAEs)

  Number (%) of patients with treatment-emergent AEs

  Treatment Period: 8 weeks

Secondary Outcomes (2)

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

  Treatment Period: 8 weeks

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

  Treatment Period: 8 weeks

Study Arms (2)

Drug - Pimavanserin

EXPERIMENTAL

Drug: Pimavanserin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pimavanserin DRUG

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

Drug - Pimavanserin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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:
• i. Behavioral variant frontotemporal dementia
• ii. Progressive supranuclear palsy
• iii. Corticobasal degeneration
• e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (104)

Cognitive Clinical Trials

Gilbert, Arizona, 85296, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Indago Research & Health Center Inc

Hialeah, Florida, 33012, United States

Location

Reliable Clinical Research, LLC

Hialeah, Florida, 33012, United States

Location

Axcess Medical Research

Loxahatchee Groves, Florida, 33470, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Global Medical Institutes

Miami, Florida, 33125, United States

Location

Future Care Solution, LLC

Miami, Florida, 33165, United States

Location

MediClear Medical & Research Center, Inc.

Miami, Florida, 33165, United States

Location

Novel Clinical Research LLC

Miami, Florida, 33186, United States

Location

Laszlo J Mate, MD, PA

North Palm Beach, Florida, 33408, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Synexus Clinical Research US

The Villages, Florida, 32162, United States

Location

Boston Center Memory

Newton, Massachusetts, 02459, United States

Location

Cognitive Clinical Trials LLC

Papillion, Nebraska, 68046, United States

Location

The NeuroCognitive Institute

Mount Arlington, New Jersey, 07856, United States

Location

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Insight Clinical Trials LLC

Shaker Heights, Ohio, 44122, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Central for Biomedical Research, LLC

Knoxville, Tennessee, 37909, United States

Location

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

Burgas, 8000, Bulgaria

Location

UMHAT Psych clin for gen psychiatry and addictions

Pleven, 5800, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

Diagnostic Consultative Centre, 2, N. Vaptzarov Street

Varna, 9000, Bulgaria

Location

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

Varna, 9000, Bulgaria

Location

Mental Health Center Vratza EOOD, 1 Belasitsa St

Vratsa, 3000, Bulgaria

Location

E.S.E. Hospital Mental de Antioquia

Bello, Antioquia, 51053, Colombia

Location

Centr Investigaciones y Proyectos en Neurociencias

Barranquilla, Atlántico, 080020, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, 66001, Colombia

Location

Centro de Investigaciones del Sistema Nervioso

Bogotá, 111166, Colombia

Location

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

Kladno, 27204, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 77900, Czechia

Location

A-shine s.r.o./ Lekarna Centrum

Pilsen, 31200, Czechia

Location

AD71, s.r.o.,/Hostivarska Iekarna

Prague, 10200, Czechia

Location

Axon Clinical

Prague, 1500, Czechia

Location

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

Prague, 16010, Czechia

Location

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

Říčany, 25101, Czechia

Location

Petre Sarajishvili Institute of Neurology LLC

Tbilisi, 0112, Georgia

Location

Pineo Medical Ecosystem LTD

Tbilisi, 0114, Georgia

Location

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, 0159, Georgia

Location

Health Institute LLC

Tbilisi, 0160, Georgia

Location

S. Khechinashvili University Hospital LLC

Tbilisi, 0179, Georgia

Location

Hospital Universitario Saltillo

Saltillo, Coahuila, 25000, Mexico

Location

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, Delegacion Tlalpan, 14269, Mexico

Location

Centro Regional para Adulto Mayor, Hsp Univ, JEG

Monterrey, Nuevo León, 64460, Mexico

Location

Clinicos y Especialidades Medicas

Monterrey, Nuevo León, 64620, Mexico

Location

Christus Muguerza Hospital Sur

Monterrey, Nuevo León, 64988, Mexico

Location

Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych

Plewiska, Poznan, 62-064, Poland

Location

MlynowaMed SP Psych Dr. Joanna Lazarcyck

Bialystok, 15-404, Poland

Location

Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski

Bialystok, 15-464, Poland

Location

Przychodnia Srodmiescie Sp. z.o.o.

Bydgoszcz, 85-080, Poland

Location

ISPL Wieslaw Jerzy Cubala

Gdansk, 80-438, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska Synap

Katowice, 40-123, Poland

Location

Silmedic Sp. z.o.o.

Katowice, 40-282, Poland

Location

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

Krakow, 31-505, Poland

Location

Centrum Medyczne HCP Sp. z.o.o.

Poznan, 61-485, Poland

Location

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

Pruszcz Gdański, 83-000, Poland

Location

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

Siemianowice Śląskie, 41-100, Poland

Location

Neuro-care

Siemianowice Śląskie, 41-100, Poland

Location

RCMed Oddzial Sochaczew, ul. _eromskiego 41A

Sochaczew, 96-500, Poland

Location

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Cluj, 400012, Romania

Location

Spitalul clinic CF Constanta, Sectia Neurologie

Constanța, 900123, Romania

Location

Med Anima SRL, Clinica de psihiatrie

Iași, 700004, Romania

Location

S.C. Carpe Diem SRL

Sibiu, 550281, Romania

Location

Regional Specialized Psychiatric Hospital #2

Tonnel’nyy, Kochubeev District, 357034, Russia

Location

Federal Siberian Sci Clinical Center of Med and Bio

Krasnoyarsk, Krasnoyarksk Region, 660037, Russia

Location

Clinic "Hundred Years"

Tomsk, Tomsk Oblast, 634009, Russia

Location

Mental Health Research Center

Moscow, 115522, Russia

Location

City Clinical Hospital #34

Novosibirsk, 630054, Russia

Location

Leningrad Regional Psychoneurological Dispensary

Roshchino, 188820, Russia

Location

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, 190121, Russia

Location

FSBI NMRC PN n.a. V.M. Bekhterev

Saint Petersburg, 193167, Russia

Location

City Psychiatric Hospital #3

Saint Petersburg, 197341, Russia

Location

Samara Psychiatric Hospital

Samara, 443016, Russia

Location

Saratov City Clinical Hospital V. I. Razumovsky

Saratov, 410028, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

Stavropol Regional Clin Spec Psych Hospital #1

Stavropol, 355038, Russia

Location

CHC Dr Dragisa Misovic- Dedinje

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia, Clinic for Psychiatry

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinic for Psychiatric Diseases Dr. Laza Lazarevic

Belgrade, 18000, Serbia

Location

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

Belgrade, 34000, Serbia

Location

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, 26220, Serbia

Location

Clinical Center Kragujevac, Clinic for Neurology

Kragujevac, 34000, Serbia

Location

Clinical Center Kragujevac, Clinic of Psychiatry

Kragujevac, 34000, Serbia

Location

Clinical Center Nis, Clinic for Psychiatry

Toponica, 18202, Serbia

Location

General Hospital Valjevo, Department for Neurology

Valjevo, 14000, Serbia

Location

Neurology Practice

Pretoria, Gauteng, 0014, South Africa

Location

Dr. Stanley Lipshitz Clinic Inc.

Sandton, Gauteng, 2146, South Africa

Location

Flexivest Fourteen Research Centre Potocnik F C V

Durbanville, Western Cape, 7500, South Africa

Location

Dnipr Regional Clinical Hospital n.a. Mechnikov

Dnipro, 49005, Ukraine

Location

I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, 49005, Ukraine

Location

Dnipropetrovsk Regional Rehabilitation Hospital

Dnipro, 49128, Ukraine

Location

Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital

Ivano-Frankivsk, 76014, Ukraine

Location

Institute of Neruology, Nat Acad of Med Sci of UKR

Kharkiv, 61068, Ukraine

Location

Institute of Neurology

Kharkiv, 61068, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

Kyiv Regional Medical Incorp. Psychiatria, Center

Kyiv, 04080, Ukraine

Location

Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str

Kyiv, 8630, Ukraine

Location

Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.

Ternopil, 46027, Ukraine

Location

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, Ukraine

Location

Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

Zaporizhzhya, 69600, Ukraine

Location

Zaporizhzhya Reg. Hospital, Neurology Dpt

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 38427485 DERIVED

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

58-261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: July 2, 2018
• Study Start: May 21, 2018
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13); GE (5); SE (10); ZA (3); ME (5); US (21); UA (13); CO (4); BU (6); PL (13); CZ (7); RO (4)