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

Phase 3

Completed

• Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
• Interventions: Drug: Pimavanserin; Drug: Placebo

• Registration Number: NCT03575052
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-09
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-02
• Primary Completion: 2022-05-06
• Study Completion: 2022-05-06
• Status Verified: 2024-12
• Results First Submitted: 2024-12-10
• Results First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Results First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 784

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)

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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

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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug - Pimavanserin	Pimavanserin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events (TEAEs)	Treatment Period: 8 weeks	Number (%) of patients with treatment-emergent AEs

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)	Treatment Period: 8 weeks	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.
Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)	Treatment Period: 8 weeks	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.

Trial Locations

Locations (104)

RCMed Oddzial Sochaczew, ul. _eromskiego 41A; 🇵🇱 Sochaczew, Poland

Boston Center Memory; 🇺🇸 Newton, Massachusetts, United States

Reliable Clinical Research, LLC; 🇺🇸 Hialeah, Florida, United States

Health Institute LLC; 🇬🇪 Tbilisi, Georgia

Laszlo J Mate, MD, PA; 🇺🇸 North Palm Beach, Florida, United States

Synexus Clinical Research US; 🇺🇸 The Villages, Florida, United States

AD71, s.r.o., /,Lekarna DPS Recruiting; 🇨🇿 Říčany, Czechia

Indago Research & Health Center Inc; 🇺🇸 Hialeah, Florida, United States

Global Medical Institutes; 🇺🇸 Miami, Florida, United States

Axcess Medical Research; 🇺🇸 Loxahatchee Groves, Florida, United States

A-shine s.r.o./ Lekarna Centrum; 🇨🇿 Plzen, Czechia

BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113; 🇨🇿 Kladno, Czechia

Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero; 🇧🇬 Bourgas, Bulgaria

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

AD71, s.r.o.,/Hostivarska Iekarna; 🇨🇿 Praha 10, Czechia

S.C. Carpe Diem SRL; 🇷🇴 Sibiu, Romania

Leningrad Regional Psychoneurological Dispensary; 🇷🇺 Roshchino, Russian Federation

Spitalul clinic CF Constanta, Sectia Neurologie; 🇷🇴 Constanta, Romania

Stavropol Regional Clin Spec Psych Hospital #1; 🇷🇺 Stavropol', Russian Federation

Samara Psychiatric Hospital; 🇷🇺 Samara, Russian Federation

Dr. Stanley Lipshitz Clinic Inc.; 🇿🇦 Sandton, Gauteng, South Africa

City Psychiatric Hospital #3; 🇷🇺 Saint Petersburg, Russian Federation

Smolensk State Medical University; 🇷🇺 Smolensk, Russian Federation

CHC Dr Dragisa Misovic- Dedinje; 🇷🇸 Belgrade, Serbia

Flexivest Fourteen Research Centre Potocnik F C V; 🇿🇦 Durbanville, Western Cape, South Africa

Neurology Practice; 🇿🇦 Pretoria, Gauteng, South Africa

Zaporizhzhya Reg. Hospital, Neurology Dpt; 🇺🇦 Zaporizhzhya, Ukraine

Premier Clinical Research Institute, Inc.; 🇺🇸 Miami, Florida, United States

MediClear Medical & Research Center, Inc.; 🇺🇸 Miami, Florida, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

UMHAT Psych clin for gen psychiatry and addictions; 🇧🇬 Pleven, Bulgaria

Axon Clinical; 🇨🇿 Praha 5, Czechia

Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych; 🇵🇱 Plewiska, Poznan, Poland

Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3; 🇵🇱 Kraków, Poland

Federal Siberian Sci Clinical Center of Med and Bio; 🇷🇺 Krasnoyarsk, Krasnoyarksk Region, Russian Federation

Clinic "Hundred Years"; 🇷🇺 Tomsk, Tomsk Region, Russian Federation

Mental Health Research Center; 🇷🇺 Moscow, Russian Federation

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju; 🇷🇸 Belgrade, Serbia

Clinical Center Kragujevac, Clinic of Psychiatry; 🇷🇸 Kragujevac, Serbia

Kyiv Regional Medical Incorp. Psychiatria, Center; 🇺🇦 Kyiv, Ukraine

Petre Sarajishvili Institute of Neurology LLC; 🇬🇪 Tbilisi, Georgia

Clinicos y Especialidades Medicas; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Przychodnia Srodmiescie Sp. z.o.o.; 🇵🇱 Bydgoszcz, Poland

Clinical Center of Serbia, Clinic for Psychiatry; 🇷🇸 Belgrade, Serbia

Clinical Center Kragujevac, Clinic for Neurology; 🇷🇸 Kragujevac, Serbia

Cognitive Clinical Trials; 🇺🇸 Gilbert, Arizona, United States

Diagnostic Consultative Centre, 2, N. Vaptzarov Street; 🇧🇬 Varna, Bulgaria

Cognitive Clinical Trials LLC; 🇺🇸 Papillion, Nebraska, United States

Centro de Investigaciones del Sistema Nervioso; 🇨🇴 Bogota, Colombia

Tbilisi Heart and Vascular Clinic LTD; 🇬🇪 Tbilisi, Georgia

Hospital Universitario Saltillo; 🇲🇽 Saltillo, Coahuila, Mexico

ISPL Wieslaw Jerzy Cubala; 🇵🇱 Gdańsk, Poland

Spitalul Clinic Judetean de Urgenta Cluj-Napoca; 🇷🇴 Cluj-Napoca, Cluj, Romania

Central for Biomedical Research, LLC; 🇺🇸 Knoxville, Tennessee, United States

Psynapsis Salud Mental S.A.; 🇨🇴 Pereira, Risaralda, Colombia

Mental Health Center Vratza EOOD, 1 Belasitsa St; 🇧🇬 Vratsa, Bulgaria

Centr Investigaciones y Proyectos en Neurociencias; 🇨🇴 Barranquilla, Atlantico, Colombia

Pineo Medical Ecosystem LTD; 🇬🇪 Tbilisi, Georgia

S. Khechinashvili University Hospital LLC; 🇬🇪 Tbilisi, Georgia

Centrum Medyczne HCP Sp. z.o.o.; 🇵🇱 Poznań, Poland

Neuro-Care Sp. z.o.o. sp. Komandytowa; 🇵🇱 Siemianowice Śląskie, Poland

Regional Specialized Psychiatric Hospital #2; 🇷🇺 Tonnel'nyy, Kochubeev District, Russian Federation

Military Medical Academy; 🇷🇸 Belgrade, Serbia

Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology; 🇺🇦 Zaporizhzhya, Ukraine

The NeuroCognitive Institute; 🇺🇸 Mount Arlington, New Jersey, United States

E.S.E. Hospital Mental de Antioquia; 🇨🇴 Bello, Antioquia, Colombia

DCC Sv. Vrach and Sv. Sv. Kozma and Damyan; 🇧🇬 Sofia, Bulgaria

Christus Muguerza Hospital Sur; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski; 🇵🇱 Białystok, Poland

Silmedic Sp. z.o.o.; 🇵🇱 Katowice, Poland

NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz; 🇵🇱 Pruszcz Gdański, Poland

St. Nicholas the Wonder Worker Psychiatric Hospital; 🇷🇺 Saint Petersburg, Russian Federation

Clinic for Psychiatric Diseases Dr. Laza Lazarevic; 🇷🇸 Belgrade, Serbia

Clinical Center Nis, Clinic for Psychiatry; 🇷🇸 Toponica, Serbia

Instituto Nacional de Neurologia y Neurocirugia; 🇲🇽 Ciudad de Mexico, Delegacion Tlalpan, Mexico

Centro Regional para Adulto Mayor, Hsp Univ, JEG; 🇲🇽 Monterrey, Nuevo Leon, Mexico

MlynowaMed SP Psych Dr. Joanna Lazarcyck; 🇵🇱 Bialystok, Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska Synap; 🇵🇱 Katowice, Poland

Neuro-care; 🇵🇱 Siemianowice Śląskie, Poland

Med Anima SRL, Clinica de psihiatrie; 🇷🇴 Iasi, Romania

Special Hospital for Psychiatric Diseases "Kovin"; 🇷🇸 Kovin, Serbia

General Hospital Valjevo, Department for Neurology; 🇷🇸 Valjevo, Serbia

Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str; 🇺🇦 Kyiv, Ukraine

City Clinical Hospital #34; 🇷🇺 Novosibirsk, Russian Federation

FSBI NMRC PN n.a. V.M. Bekhterev; 🇷🇺 Saint Petersburg, Russian Federation

Saratov City Clinical Hospital V. I. Razumovsky; 🇷🇺 Saratov, Russian Federation

I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital; 🇺🇦 Dnipro, Ukraine

Institute of Neurology; 🇺🇦 Kharkiv, Ukraine

Dnipr Regional Clinical Hospital n.a. Mechnikov; 🇺🇦 Dnipro, Ukraine

Dnipropetrovsk Regional Rehabilitation Hospital; 🇺🇦 Dnipro, Ukraine

Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital; 🇺🇦 Ivano-Frankivsk, Ukraine

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

Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.; 🇺🇦 Ternopil', Ukraine

Institute of Neruology, Nat Acad of Med Sci of UKR; 🇺🇦 Kharkiv, 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

Future Care Solution, LLC; 🇺🇸 Miami, Florida, United States

Novel Clinical Research LLC; 🇺🇸 Miami, Florida, United States

Insight Clinical Trials LLC; 🇺🇸 Shaker Heights, Ohio, United States

Suburban Research Associates; 🇺🇸 Media, Pennsylvania, United States

Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1; 🇨🇿 Praha 6, Czechia

Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd; 🇧🇬 Varna, Bulgaria

University of South Florida; 🇺🇸 Tampa, Florida, United States

UNC Hospital; 🇺🇸 Chapel Hill, North Carolina, United States