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

NCT ID: NCT03575052

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 784 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2022-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug - Pimavanserin

Group Type: EXPERIMENTAL

Pimavanserin

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Pimavanserin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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:

1. The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent

2. The subject must provide written (if capable) informed assent

2. Subject requires some or complete assistance with one or more of the following:

1. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR

2. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)

3. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):

1. Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force

2. Dementia with Lewy bodies (DLB)

3. All-cause dementia, possible or probable Alzheimer's disease (AD)

4. 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)

4. Has a designated study partner/caregiver

5. Can come to the clinic for study visits with a study partner/caregiver

6. 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.

7. 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)

Exclusion Criteria

1. Is in hospice, is receiving end-of-life palliative care, or is bedridden

2. Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)

3. 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

4. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death

5. Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:

1. intracranial mass lesion

2. vascular malformation

3. evidence of >4 hemosiderin deposits

6. 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.

7. 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cognitive Clinical Trials

Gilbert, Arizona, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Indago Research & Health Center Inc

Hialeah, Florida, United States

Reliable Clinical Research, LLC

Hialeah, Florida, United States

Axcess Medical Research

Loxahatchee Groves, Florida, United States

Premier Clinical Research Institute, Inc.

Miami, Florida, United States

Global Medical Institutes

Miami, Florida, United States

Future Care Solution, LLC

Miami, Florida, United States

MediClear Medical & Research Center, Inc.

Miami, Florida, United States

Novel Clinical Research LLC

Miami, Florida, United States

Laszlo J Mate, MD, PA

North Palm Beach, Florida, United States

University of South Florida

Tampa, Florida, United States

Synexus Clinical Research US

The Villages, Florida, United States

Boston Center Memory

Newton, Massachusetts, United States

Cognitive Clinical Trials LLC

Papillion, Nebraska, United States

The NeuroCognitive Institute

Mount Arlington, New Jersey, United States

UNC Hospital

Chapel Hill, North Carolina, United States

Insight Clinical Trials LLC

Shaker Heights, Ohio, United States

Suburban Research Associates

Media, Pennsylvania, United States

Central for Biomedical Research, LLC

Knoxville, Tennessee, United States

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

Burgas, , Bulgaria

UMHAT Psych clin for gen psychiatry and addictions

Pleven, , Bulgaria

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

Sofia, , Bulgaria

Diagnostic Consultative Centre, 2, N. Vaptzarov Street

Varna, , Bulgaria

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

Varna, , Bulgaria

Mental Health Center Vratza EOOD, 1 Belasitsa St

Vratsa, , Bulgaria

E.S.E. Hospital Mental de Antioquia

Bello, Antioquia, Colombia

Centr Investigaciones y Proyectos en Neurociencias

Barranquilla, Atlántico, Colombia

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, Colombia

Centro de Investigaciones del Sistema Nervioso

Bogotá, , Colombia

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

Kladno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

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

Pilsen, , Czechia

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

Prague, , Czechia

Axon Clinical

Prague, , Czechia

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

Prague, , Czechia

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

Říčany, , Czechia

Petre Sarajishvili Institute of Neurology LLC

Tbilisi, , Georgia

Pineo Medical Ecosystem LTD

Tbilisi, , Georgia

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, , Georgia

Health Institute LLC

Tbilisi, , Georgia

S. Khechinashvili University Hospital LLC

Tbilisi, , Georgia

Hospital Universitario Saltillo

Saltillo, Coahuila, Mexico

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, Delegacion Tlalpan, Mexico

Centro Regional para Adulto Mayor, Hsp Univ, JEG

Monterrey, Nuevo León, Mexico

Clinicos y Especialidades Medicas

Monterrey, Nuevo León, Mexico

Christus Muguerza Hospital Sur

Monterrey, Nuevo León, Mexico

Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych

Plewiska, Poznan, Poland

MlynowaMed SP Psych Dr. Joanna Lazarcyck

Bialystok, , Poland

Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski

Bialystok, , Poland

Przychodnia Srodmiescie Sp. z.o.o.

Bydgoszcz, , Poland

ISPL Wieslaw Jerzy Cubala

Gdansk, , Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska Synap

Katowice, , Poland

Silmedic Sp. z.o.o.

Katowice, , Poland

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

Krakow, , Poland

Centrum Medyczne HCP Sp. z.o.o.

Poznan, , Poland

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

Pruszcz Gdański, , Poland

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

Siemianowice Śląskie, , Poland

Neuro-care

Siemianowice Śląskie, , Poland

RCMed Oddzial Sochaczew, ul. _eromskiego 41A

Sochaczew, , Poland

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Spitalul clinic CF Constanta, Sectia Neurologie

Constanța, , Romania

Med Anima SRL, Clinica de psihiatrie

Iași, , Romania

S.C. Carpe Diem SRL

Sibiu, , Romania

Regional Specialized Psychiatric Hospital #2

Tonnel'nyy, Kochubeev District, Russia

Federal Siberian Sci Clinical Center of Med and Bio

Krasnoyarsk, Krasnoyarksk Region, Russia

Clinic "Hundred Years"

Tomsk, Tomsk Oblast, Russia

Mental Health Research Center

Moscow, , Russia

City Clinical Hospital #34

Novosibirsk, , Russia

Leningrad Regional Psychoneurological Dispensary

Roshchino, , Russia

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

City Psychiatric Hospital #3

Saint Petersburg, , Russia

Samara Psychiatric Hospital

Samara, , Russia

Saratov City Clinical Hospital V. I. Razumovsky

Saratov, , Russia

Smolensk State Medical University

Smolensk, , Russia

Stavropol Regional Clin Spec Psych Hospital #1

Stavropol, , Russia

CHC Dr Dragisa Misovic- Dedinje

Belgrade, , Serbia

Clinical Center of Serbia, Clinic for Psychiatry

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinic for Psychiatric Diseases Dr. Laza Lazarevic

Belgrade, , Serbia

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

Belgrade, , Serbia

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, , Serbia

Clinical Center Kragujevac, Clinic for Neurology

Kragujevac, , Serbia

Clinical Center Kragujevac, Clinic of Psychiatry

Kragujevac, , Serbia

Clinical Center Nis, Clinic for Psychiatry

Toponica, , Serbia

General Hospital Valjevo, Department for Neurology

Valjevo, , Serbia

Neurology Practice

Pretoria, Gauteng, South Africa

Dr. Stanley Lipshitz Clinic Inc.

Sandton, Gauteng, South Africa

Flexivest Fourteen Research Centre Potocnik F C V

Durbanville, Western Cape, South Africa

Dnipr Regional Clinical Hospital n.a. Mechnikov

Dnipro, , Ukraine

I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , Ukraine

Dnipropetrovsk Regional Rehabilitation Hospital

Dnipro, , Ukraine

Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital

Ivano-Frankivsk, , Ukraine

Institute of Neruology, Nat Acad of Med Sci of UKR

Kharkiv, , Ukraine

Institute of Neurology

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

Kyiv Regional Medical Incorp. Psychiatria, Center

Kyiv, , Ukraine

Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str

Kyiv, , Ukraine

Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.

Ternopil, , 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, 109 Pyrogova str.

Vinnytsia, , Ukraine

Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

Zaporizhzhya, , Ukraine

Zaporizhzhya Reg. Hospital, Neurology Dpt

Zaporizhzhya, , Ukraine

Countries

United States; Bulgaria; Colombia; Czechia; Georgia; Mexico; Poland; Romania; Russia; Serbia; South Africa; Ukraine

References

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.

Reference Type: DERIVED

PMID: 38427485 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003536-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACP-103-046

Identifier Type: -

Identifier Source: org_study_id