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

Sponsor
ACADIA Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03575052
Collaborator
(none)
784
Enrollment
104
Locations
2
Arms
47.5
Actual Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
784 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 21, 2018
Actual Primary Completion Date :
May 6, 2022
Actual Study Completion Date :
May 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug - Pimavanserin

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

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

Outcome Measures

Primary Outcome Measures

  1. Treatment-emergent adverse events (TEAEs) [Treatment Period: 8 weeks]

    Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease

Secondary Outcome Measures

  1. Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) [Treatment Period: 8 weeks]

  2. Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE) [Treatment Period: 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

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

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

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

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

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

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

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

  9. Dementia with Lewy bodies (DLB)

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

  11. Frontotemporal degeneration spectrum disorders, including possible or probable:

  1. Behavioral variant frontotemporal dementia

  1. Progressive supranuclear palsy

  2. Corticobasal degeneration

  1. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)

  1. Has a designated study partner/caregiver

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

  3. 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.

  4. 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:

  6. intracranial mass lesion

  7. vascular malformation

  8. evidence of >4 hemosiderin deposits

  9. 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.

  10. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cognitive Clinical Trials Gilbert Arizona United States 85296
2 ATP Clinical Research, Inc. Costa Mesa California United States 92626
3 Syrentis Clinical Research Santa Ana California United States 92705
4 Indago Research & Health Center Inc Hialeah Florida United States 33012
5 Reliable Clinical Research, LLC Hialeah Florida United States 33012
6 Axcess Medical Research Loxahatchee Groves Florida United States 33470
7 Premier Clinical Research Institute, Inc. Miami Florida United States 33122
8 Global Medical Institutes Miami Florida United States 33125
9 Future Care Solution, LLC Miami Florida United States 33165
10 MediClear Medical & Research Center, Inc. Miami Florida United States 33165
11 Novel Clinical Research LLC Miami Florida United States 33186
12 Laszlo J Mate, MD, PA North Palm Beach Florida United States 33408
13 University of South Florida Tampa Florida United States 33613
14 Synexus Clinical Research US The Villages Florida United States 32162
15 Boston Center Memory Newton Massachusetts United States 02459
16 Cognitive Clinical Trials LLC Papillion Nebraska United States 68046
17 The NeuroCognitive Institute Mount Arlington New Jersey United States 07856
18 UNC Hospital Chapel Hill North Carolina United States 27599
19 Insight Clinical Trials LLC Shaker Heights Ohio United States 44122
20 Suburban Research Associates Media Pennsylvania United States 19063
21 Central for Biomedical Research, LLC Knoxville Tennessee United States 37909
22 Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero Bourgas Bulgaria 8000
23 UMHAT Psych clin for gen psychiatry and addictions Pleven Bulgaria 5800
24 DCC Sv. Vrach and Sv. Sv. Kozma and Damyan Sofia Bulgaria 1408
25 Diagnostic Consultative Centre, 2, N. Vaptzarov Street Varna Bulgaria 9000
26 Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd Varna Bulgaria 9000
27 Mental Health Center Vratza EOOD, 1 Belasitsa St Vratsa Bulgaria 3000
28 E.S.E. Hospital Mental de Antioquia Bello Antioquia Colombia 51053
29 Centr Investigaciones y Proyectos en Neurociencias Barranquilla Atlantico Colombia 080020
30 Psynapsis Salud Mental S.A. Pereira Risaralda Colombia 66001
31 Centro de Investigaciones del Sistema Nervioso Bogota Colombia 111166
32 BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113 Kladno Czechia 27204
33 Fakultni nemocnice Olomouc Olomouc Czechia 77900
34 A-shine s.r.o./ Lekarna Centrum Plzen Czechia 31200
35 AD71, s.r.o.,/Hostivarska Iekarna Praha 10 Czechia 10200
36 Axon Clinical Praha 5 Czechia 1500
37 Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1 Praha 6 Czechia 16010
38 AD71, s.r.o., /,Lekarna DPS Recruiting Říčany Czechia 25101
39 Petre Sarajishvili Institute of Neurology LLC Tbilisi Georgia 0112
40 Pineo Medical Ecosystem LTD Tbilisi Georgia 0114
41 Tbilisi Heart and Vascular Clinic LTD Tbilisi Georgia 0159
42 Health Institute LLC Tbilisi Georgia 0160
43 S. Khechinashvili University Hospital LLC Tbilisi Georgia 0179
44 Hospital Universitario Saltillo Saltillo Coahuila Mexico 25000
45 Instituto Nacional de Neurologia y Neurocirugia Ciudad de Mexico Delegacion Tlalpan Mexico 14269
46 Centro Regional para Adulto Mayor, Hsp Univ, JEG Monterrey Nuevo Leon Mexico 64460
47 Clinicos y Especialidades Medicas Monterrey Nuevo Leon Mexico 64620
48 Christus Muguerza Hospital Sur Monterrey Nuevo Leon Mexico 64988
49 Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych Plewiska Poznan Poland 62-064
50 MlynowaMed SP Psych Dr. Joanna Lazarcyck Bialystok Poland 15-404
51 Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski Białystok Poland 15-464
52 Przychodnia Srodmiescie Sp. z.o.o. Bydgoszcz Poland 85-080
53 ISPL Wieslaw Jerzy Cubala Gdańsk Poland 80-438
54 NZOZ Wielospecjalistyczna Poradnia Lekarska Synap Katowice Poland 40-123
55 Silmedic Sp. z.o.o. Katowice Poland 40-282
56 Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3 Kraków Poland 31-505
57 Centrum Medyczne HCP Sp. z.o.o. Poznań Poland 61-485
58 NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz Pruszcz Gdański Poland 83-000
59 Neuro-Care Sp. z.o.o. sp. Komandytowa Siemianowice Śląskie Poland 41-100
60 Neuro-care Siemianowice Śląskie Poland 41-100
61 RCMed Oddzial Sochaczew, ul. _eromskiego 41A Sochaczew Poland 96-500
62 Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca Cluj Romania 400012
63 Spitalul clinic CF Constanta, Sectia Neurologie Constanta Romania 900123
64 Med Anima SRL, Clinica de psihiatrie Iasi Romania 700004
65 S.C. Carpe Diem SRL Sibiu Romania 550281
66 Regional Specialized Psychiatric Hospital #2 Tonnel'nyy Kochubeev District Russian Federation 357034
67 Federal Siberian Sci Clinical Center of Med and Bio Krasnoyarsk Krasnoyarksk Region Russian Federation 660037
68 Clinic "Hundred Years" Tomsk Tomsk Region Russian Federation 634009
69 Mental Health Research Center Moscow Russian Federation 115522
70 City Clinical Hospital #34 Novosibirsk Russian Federation 630054
71 Leningrad Regional Psychoneurological Dispensary Roshchino Russian Federation 188820
72 St. Nicholas the Wonder Worker Psychiatric Hospital Saint Petersburg Russian Federation 190121
73 FSBI NMRC PN n.a. V.M. Bekhterev Saint Petersburg Russian Federation 193167
74 City Psychiatric Hospital #3 Saint Petersburg Russian Federation 197341
75 Samara Psychiatric Hospital Samara Russian Federation 443016
76 Saratov City Clinical Hospital V. I. Razumovsky Saratov Russian Federation 410028
77 Smolensk State Medical University Smolensk Russian Federation 214019
78 Stavropol Regional Clin Spec Psych Hospital #1 Stavropol' Russian Federation 355038
79 CHC Dr Dragisa Misovic- Dedinje Belgrade Serbia 11000
80 Clinical Center of Serbia, Clinic for Psychiatry Belgrade Serbia 11000
81 Military Medical Academy Belgrade Serbia 11000
82 Clinic for Psychiatric Diseases Dr. Laza Lazarevic Belgrade Serbia 18000
83 Klinicki Centar Srbije (KCS)- Klinika za nerurologiju Belgrade Serbia 34000
84 Special Hospital for Psychiatric Diseases "Kovin" Kovin Serbia 26220
85 Clinical Center Kragujevac, Clinic for Neurology Kragujevac Serbia 34000
86 Clinical Center Kragujevac, Clinic of Psychiatry Kragujevac Serbia 34000
87 Clinical Center Nis, Clinic for Psychiatry Toponica Serbia 18202
88 General Hospital Valjevo, Department for Neurology Valjevo Serbia 14000
89 Neurology Practice Pretoria Gauteng South Africa 0014
90 Dr. Stanley Lipshitz Clinic Inc. Sandton Gauteng South Africa 2146
91 Flexivest Fourteen Research Centre Potocnik F C V Durbanville Western Cape South Africa 7500
92 Dnipr Regional Clinical Hospital n.a. Mechnikov Dnipro Ukraine 49005
93 I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital Dnipro Ukraine 49005
94 Dnipropetrovsk Regional Rehabilitation Hospital Dnipro Ukraine 49128
95 Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital Ivano-Frankivsk Ukraine 76014
96 Institute of Neruology, Nat Acad of Med Sci of UKR Kharkiv Ukraine 61068
97 Institute of Neurology Kharkiv Ukraine 61068
98 Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str Kharkiv Ukraine 61068
99 Kyiv Regional Medical Incorp. Psychiatria, Center Kyiv Ukraine 04080
100 Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str Kyiv Ukraine 8630
101 Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str. Ternopil' Ukraine 46027
102 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 21037
103 Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology Zaporizhzhya Ukraine 69600
104 Zaporizhzhya Reg. Hospital, Neurology Dpt Zaporizhzhya Ukraine 69600

Sponsors and Collaborators

  • ACADIA Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03575052
Other Study ID Numbers:
  • ACP-103-046
  • 2017-003536-36
First Posted:
Jul 2, 2018
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neurodegenerative Diseases
Pimavanserin

Study Results

No Results Posted as of Aug 15, 2022