En studie for å vurdere effektiviteten og sikkerheten til ITI-1284 i behandling av psykose assosiert med Alzheimers sykdom
En multisenter, randomisert, dobbeltblind, placebokontrollert, fleksibel dosestudie for å vurdere effektiviteten, sikkerheten og toleransen til ITI-1284 hos pasienter med psykose assosiert med Alzheimers sykdom
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Blagoevgrad, Bulgaria, 2700
- Fullført
- Medical Center Sv Dimitar Blagoevgrad
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Cherven Bryag, Bulgaria, 5980
- Rekruttering
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Sofia, Bulgaria, 1680
- Rekruttering
- Medical Center Intermedica, OOD
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Sofia, Bulgaria, 1408
- Rekruttering
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulgaria, 1510
- Rekruttering
- Medical Center Hera EOOD
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Sofia, Bulgaria, 1377
- Rekruttering
- Mental Health Centre Prof. N Shipkovenski EOOD
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Stara Zagora, Bulgaria, 6003
- Rekruttering
- UMHAT Prof. Dr. St. Kirkovich AD
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Vratsa, Bulgaria, 3000
- Fullført
- Mental Health Center - Vratsa EOOD
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California
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Anaheim, California, Forente stater, 92805
- Rekruttering
- Advanced Research Center, Inc
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Los Alamitos, California, Forente stater, 90720
- Fullført
- Pharmacology Research Institute
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Newport Beach, California, Forente stater, 92660
- Fullført
- Wr Pri Llc
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Orange, California, Forente stater, 92866
- Fullført
- ATP Clinical Research
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Walnut Creek, California, Forente stater, 94596
- Rekruttering
- Sunwise Clinical Research
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Florida
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Bonita Springs, Florida, Forente stater, 34134
- Rekruttering
- Envision Trials LLC
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Brandon, Florida, Forente stater, 33511
- Rekruttering
- Clinical Research of Brandon
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Coral Springs, Florida, Forente stater, 33067
- Fullført
- Healthcare Innovations Institute Inc
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Delray Beach, Florida, Forente stater, 33445
- Fullført
- Brain Matters Research
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Doral, Florida, Forente stater, 33178
- Rekruttering
- Science Connections LLC
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Homestead, Florida, Forente stater, 33033
- Rekruttering
- Homestead Associates in Research Inc
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Maitland, Florida, Forente stater, 32751
- Rekruttering
- K2 Medical Research
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Miami, Florida, Forente stater, 33155-4630
- Rekruttering
- Allied Biomedical Research Institute (ABRI), Inc
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Miami, Florida, Forente stater, 33135
- Rekruttering
- Wellness Research Center
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Miami, Florida, Forente stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami, Florida, Forente stater, 33144
- Suspendert
- Ocean Blue Medical Research Center Inc.
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Miami, Florida, Forente stater, 33186
- Rekruttering
- Sunshine Medical Solution
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Orlando, Florida, Forente stater, 32803
- Fullført
- Combined Research Orlando
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Sarasota, Florida, Forente stater, 34239
- Rekruttering
- Intercoastal Medical Group
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Tampa, Florida, Forente stater, 33613
- Rekruttering
- University of South Florida
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Tampa, Florida, Forente stater, 33614
- Fullført
- Psych Me Medical Research Inc
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Georgia
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Savannah, Georgia, Forente stater, 31405
- Rekruttering
- CenExeli Research LLC
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New Jersey
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Toms River, New Jersey, Forente stater, 08755
- Rekruttering
- Bio Behavioral Health
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North Carolina
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Charlotte, North Carolina, Forente stater, 28211
- Rekruttering
- New Hope Clinical Research
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Matthews, North Carolina, Forente stater, 28105
- Rekruttering
- AMC Research, LLC
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Texas
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Cypress, Texas, Forente stater, 77065
- Rekruttering
- Horizon Clinical Research Group
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San Antonio, Texas, Forente stater, 78229-3900
- Fullført
- University of Texas Health Science Center at San Antonio
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Washington
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Bellevue, Washington, Forente stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Arzignano, Italia, 36071
- Rekruttering
- Ospedale di Arzignano
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Brescia, Italia, 25123
- Rekruttering
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
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Cefalù, Italia, 90015
- Rekruttering
- Fondazione Istituto G. Giglio
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Tricase, Italia, 73039
- Rekruttering
- Ospedale Cardinale G. Panico
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Zagreb, Kroatia, 10000
- Rekruttering
- University Hospital Centre Zagreb
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Zagreb, Kroatia, 10000
- Rekruttering
- Polyclinic Neuron
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Zagreb, Kroatia, 10000
- Fullført
- University Hospital Centre Zagreb 1
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Zagreb, Kroatia, 10090
- Rekruttering
- Psychiatric Clinic "VRAPCE"
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Bydgoszcz, Polen, 85 080
- Fullført
- Przychodnia Srodmiescie SP. z o.o.
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Katowice, Polen, 40-749
- Fullført
- Neuro Care
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Ścinawa, Polen, 59-330
- Fullført
- Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu
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Bucharest, Romania, 041914
- Rekruttering
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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Bucharest, Romania, 010825
- Rekruttering
- Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
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Bucharest, Romania, 040874
- Rekruttering
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
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Bucharest, Romania, 60222
- Fullført
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
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Galati, Romania, 800179
- Rekruttering
- Spitalul De Psihiatrie Elisabeta Doamna Galaţi
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Sibiu, Romania, 550281
- Rekruttering
- SC Carpe Diem SRL
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Belgrade, Serbia, 11000
- Rekruttering
- Clinical Center Dr Dragisa Misovic Dedinje
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Kovin, Serbia, 26220
- Fullført
- Special Hospital for Psychiatric Diseases Kovin
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Kragujevac, Serbia, 34000
- Rekruttering
- University Clinical Center Kragujevac
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Niš, Serbia, 18000
- Rekruttering
- University Clinical Center NIS
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Novi Kneževac, Serbia, 23330
- Suspendert
- Special Hospital for Psychiatric Diseases Sveti Vracevi
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Banská Bystrica, Slovakia, 97404
- Fullført
- Neurologicka ambulancia MUDr.Dupejova s.r.o.
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Bratislava, Slovakia, 81369
- Suspendert
- Univerzitna nemocnica Bratislava
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Košice, Slovakia, 04190
- Rekruttering
- Univerzitna nemocnica L. Pasteura Kosice
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Košice, Slovakia, 4001
- Rekruttering
- Epamed sro
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Krompachy, Slovakia, 05342
- Rekruttering
- NEURES s r o
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Vranov nad Topľou, Slovakia, 09301
- Rekruttering
- Crystal Comfort s.r.o.
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Albacete, Spania, 02006
- Suspendert
- Hosp. Gral. de Albacete
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Zamora, Spania, 49021
- Rekruttering
- Hosp. Prov. de Zamora
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Zaragoza, Spania, 50012
- Suspendert
- Hosp. Viamed Montecanal
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Brno, Tsjekkia, 60200
- Rekruttering
- Fakultni nemocnice u sv. Anny v Brne
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Brno, Tsjekkia, 62800
- Rekruttering
- Neuro Health Centrum s r o
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Hradec Králové, Tsjekkia, 50002
- Rekruttering
- NEUROHK s r o
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Prague, Tsjekkia, 18600
- Fullført
- INEP medical s.r.o.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: ITI-1284
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ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ITI-1284-201
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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