En undersøgelse for at vurdere effektiviteten og sikkerheden af ITI-1284 i behandlingen af psykose forbundet med Alzheimers sygdom
Et multicenter, randomiseret, dobbeltblindt, placebokontrolleret, fleksibelt dosisstudie for at vurdere effektiviteten, sikkerheden og tolerabiliteten af ITI-1284 hos patienter med psykose forbundet med Alzheimers sygdom
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Blagoevgrad, Bulgarien, 2700
- Afsluttet
- Medical Center Sv Dimitar Blagoevgrad
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Cherven Bryag, Bulgarien, 5980
- Rekruttering
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Sofia, Bulgarien, 1680
- Rekruttering
- Medical Center Intermedica, OOD
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Sofia, Bulgarien, 1408
- Rekruttering
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulgarien, 1510
- Rekruttering
- Medical Center Hera EOOD
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Sofia, Bulgarien, 1377
- Rekruttering
- Mental Health Centre Prof. N Shipkovenski EOOD
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Stara Zagora, Bulgarien, 6003
- Rekruttering
- UMHAT Prof. Dr. St. Kirkovich AD
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Vratsa, Bulgarien, 3000
- Afsluttet
- Mental Health Center - Vratsa EOOD
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center, Inc
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Los Alamitos, California, Forenede Stater, 90720
- Afsluttet
- Pharmacology Research Institute
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Newport Beach, California, Forenede Stater, 92660
- Afsluttet
- Wr Pri Llc
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Orange, California, Forenede Stater, 92866
- Afsluttet
- ATP Clinical Research
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Walnut Creek, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research
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Florida
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Bonita Springs, Florida, Forenede Stater, 34134
- Rekruttering
- Envision Trials LLC
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Brandon, Florida, Forenede Stater, 33511
- Rekruttering
- Clinical Research of Brandon
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Coral Springs, Florida, Forenede Stater, 33067
- Afsluttet
- Healthcare Innovations Institute Inc
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Delray Beach, Florida, Forenede Stater, 33445
- Afsluttet
- Brain Matters Research
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Doral, Florida, Forenede Stater, 33178
- Rekruttering
- Science Connections LLC
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Homestead, Florida, Forenede Stater, 33033
- Rekruttering
- Homestead Associates in Research Inc
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Maitland, Florida, Forenede Stater, 32751
- Rekruttering
- K2 Medical Research
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Miami, Florida, Forenede Stater, 33155-4630
- Rekruttering
- Allied Biomedical Research Institute (ABRI), Inc
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Wellness Research Center
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Miami, Florida, Forenede Stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami, Florida, Forenede Stater, 33144
- Suspenderet
- Ocean Blue Medical Research Center Inc.
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Miami, Florida, Forenede Stater, 33186
- Rekruttering
- Sunshine Medical Solution
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Orlando, Florida, Forenede Stater, 32803
- Afsluttet
- Combined Research Orlando
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Sarasota, Florida, Forenede Stater, 34239
- Rekruttering
- Intercoastal Medical Group
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Tampa, Florida, Forenede Stater, 33613
- Rekruttering
- University of South Florida
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Tampa, Florida, Forenede Stater, 33614
- Afsluttet
- Psych Me Medical Research Inc
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Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Rekruttering
- CenExeli Research LLC
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New Jersey
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Toms River, New Jersey, Forenede Stater, 08755
- Rekruttering
- Bio Behavioral Health
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28211
- Rekruttering
- New Hope Clinical Research
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Matthews, North Carolina, Forenede Stater, 28105
- Rekruttering
- AMC Research, LLC
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Texas
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Cypress, Texas, Forenede Stater, 77065
- Rekruttering
- Horizon Clinical Research Group
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San Antonio, Texas, Forenede Stater, 78229-3900
- Afsluttet
- University of Texas Health Science Center at San Antonio
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Arzignano, Italien, 36071
- Rekruttering
- Ospedale di Arzignano
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Brescia, Italien, 25123
- Rekruttering
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
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Cefalù, Italien, 90015
- Rekruttering
- Fondazione Istituto G. Giglio
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Tricase, Italien, 73039
- Rekruttering
- Ospedale Cardinale G. Panico
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Zagreb, Kroatien, 10000
- Rekruttering
- University Hospital Centre Zagreb
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Zagreb, Kroatien, 10000
- Rekruttering
- Polyclinic Neuron
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Zagreb, Kroatien, 10000
- Afsluttet
- University Hospital Centre Zagreb 1
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Zagreb, Kroatien, 10090
- Rekruttering
- Psychiatric Clinic "VRAPCE"
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Bydgoszcz, Polen, 85 080
- Afsluttet
- Przychodnia Srodmiescie SP. z o.o.
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Katowice, Polen, 40-749
- Afsluttet
- Neuro Care
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Ścinawa, Polen, 59-330
- Afsluttet
- Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu
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Bucharest, Rumænien, 041914
- Rekruttering
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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Bucharest, Rumænien, 010825
- Rekruttering
- Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
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Bucharest, Rumænien, 040874
- Rekruttering
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
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Bucharest, Rumænien, 60222
- Afsluttet
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
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Galati, Rumænien, 800179
- Rekruttering
- Spitalul De Psihiatrie Elisabeta Doamna Galaţi
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Sibiu, Rumænien, 550281
- Rekruttering
- SC Carpe Diem SRL
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Belgrade, Serbien, 11000
- Rekruttering
- Clinical Center Dr Dragisa Misovic Dedinje
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Kovin, Serbien, 26220
- Afsluttet
- Special Hospital for Psychiatric Diseases Kovin
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Kragujevac, Serbien, 34000
- Rekruttering
- University Clinical Center Kragujevac
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Niš, Serbien, 18000
- Rekruttering
- University Clinical Center NIS
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Novi Kneževac, Serbien, 23330
- Suspenderet
- Special Hospital for Psychiatric Diseases Sveti Vracevi
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Banská Bystrica, Slovakiet, 97404
- Afsluttet
- Neurologicka ambulancia MUDr.Dupejova s.r.o.
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Bratislava, Slovakiet, 81369
- Suspenderet
- Univerzitna nemocnica Bratislava
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Košice, Slovakiet, 04190
- Rekruttering
- Univerzitna nemocnica L. Pasteura Kosice
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Košice, Slovakiet, 4001
- Rekruttering
- Epamed sro
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Krompachy, Slovakiet, 05342
- Rekruttering
- NEURES s r o
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Vranov nad Topľou, Slovakiet, 09301
- Rekruttering
- Crystal Comfort s.r.o.
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Albacete, Spanien, 02006
- Suspenderet
- Hosp. Gral. de Albacete
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Zamora, Spanien, 49021
- Rekruttering
- Hosp. Prov. de Zamora
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Zaragoza, Spanien, 50012
- Suspenderet
- Hosp. Viamed Montecanal
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Brno, Tjekkiet, 60200
- Rekruttering
- Fakultni nemocnice u sv. Anny v Brne
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Brno, Tjekkiet, 62800
- Rekruttering
- Neuro Health Centrum s r o
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Hradec Králové, Tjekkiet, 50002
- Rekruttering
- NEUROHK s r o
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Prague, Tjekkiet, 18600
- Afsluttet
- INEP medical s.r.o.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative [LAR]) before the initiation of any study-specific procedures in accordance with local regulations
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Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:
- Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
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Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
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Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline
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CGI-S score ≥ 4 at Screening and Baseline
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Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures
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Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)
Exclusion Criteria:
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Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (for example, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:
- Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia
- Bipolar disorder
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Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening
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The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee
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The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
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The patient is bedridden or has any significant medical condition that is unstable and would either:
- Place the patient at undue risk from study drug or undergoing study procedures; or
- Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study
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The patient is in hospice or end-of-life care
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
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Placebo rapidly disintegrating tablet, taken once daily, sublingual administration |
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Eksperimentel: ITI-1284
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ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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BEHAVE-AD psychosis subscale score
Tidsramme: Week 6
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The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36. |
Week 6
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CGI-S score
Tidsramme: Week 6
|
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients) |
Week 6
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ITI-1284-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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