En studie for å vurdere effektiviteten og sikkerheten til ITI-1284 i behandling av psykose assosiert med Alzheimers demens
En multisenter, randomisert, dobbeltblind, placebokontrollert, fleksibel dosestudie av effektiviteten, sikkerheten og toleransen til ITI-1284 hos pasienter med agitasjon assosiert med Alzheimers demens
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
Studieoversikt
Status
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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Lovech, Bulgaria, 5500
- Rekruttering
- State Psychiatric Hospital - Lovech
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Pleven, Bulgaria, 5800
- Rekruttering
- Medical Center Medconsult-Pleven
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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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California
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Anaheim, California, Forente stater, 92805
- Rekruttering
- Advanced Research Center, Inc
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Costa Mesa, California, Forente stater, 92626
- Fullført
- ATP Clinical Research
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Garden Grove, California, Forente stater, 92844
- Fullført
- National Institute Of Clinical Research
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Newport Beach, California, Forente stater, 92660
- Fullført
- Wr Pri Llc
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Walnut Creek, California, Forente stater, 94596
- Rekruttering
- Sunwise Clinical Research
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Florida
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Boca Raton, Florida, Forente stater, 33487
- Rekruttering
- SFM Clinical Research LLC
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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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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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Hialeah, Florida, Forente stater, 33012-3618
- Rekruttering
- Direct Helpers Medical Center, Inc.
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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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Maitland, Florida, Forente stater, 32751
- Rekruttering
- Neurology Associates PA
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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, 33122
- Rekruttering
- Vital Care Research
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Miami, Florida, Forente stater, 33135
- Rekruttering
- Wellness Research Center
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Miami, Florida, Forente stater, 33135
- Rekruttering
- Advanced Clinical Research Network
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Miami, Florida, Forente stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami, Florida, Forente stater, 33135
- Suspendert
- Advance Medical Research Center
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Miami, Florida, Forente stater, 33186
- Rekruttering
- Sunshine Medical Research Studies Inc
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Miami, Florida, Forente stater, 33180
- Fullført
- Miami Jewish Health System
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Orlando, Florida, Forente stater, 32803
- Rekruttering
- Charter Research
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Orlando, Florida, Forente stater, 32807
- Fullført
- Combined Research Orlando
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Tampa, Florida, Forente stater, 33614
- Rekruttering
- Psych Me Medical Research Inc
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Tampa, Florida, Forente stater, 33614
- Rekruttering
- Quantum Research Associates Corp
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West Palm Beach, Florida, Forente stater, 33407
- Rekruttering
- Premiere Research Institute at Palm Beach Neurology
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Rekruttering
- Tufts University School of Medicine
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Nevada
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Las Vegas, Nevada, Forente stater, 89121
- Rekruttering
- Oasis Clinical 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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Raleigh, North Carolina, Forente stater, 27607
- Fullført
- Eximia Clinical Research NC
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Texas
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- UT Health San Antonio
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Zagreb, Kroatia, 10000
- Rekruttering
- University Hospital Centre Zagreb
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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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Zagreb, Kroatia, 10090
- Rekruttering
- Psychiatric Hospital Sveti Ivan
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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
- Rekruttering
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
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Com Sanpetru, Romania, 507190
- Rekruttering
- Spitalul de Psihiatrie si Neurologie Brasov
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Sibiu, Romania, 550281
- Rekruttering
- SC Carpe Diem SRL
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Belgrade, Serbia, 11000
- Rekruttering
- Institute of Mental Health Serbia
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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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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
- Rekruttering
- Neurologicka ambulancia MUDr.Dupejova s.r.o.
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Bratislava, Slovakia, 81369
- Rekruttering
- Univerzitna nemocnica Bratislava
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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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Svidník, Slovakia, 089 01
- Rekruttering
- Psychiatricka Ambulancia Centrum Zdravia R.B.K. 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
- Rekruttering
- Hosp. Gral. de Albacete
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Badalona, Spania, 08916
- Rekruttering
- Hospital Universitari Germans Trias i Pujol
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Málaga, Spania, 29004
- Rekruttering
- Hosp. Quirónsalud Málaga
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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, 602 00
- Rekruttering
- Fakultni nemocnice u sv. Anny v Brne
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Choceň, Tsjekkia, 56501
- Rekruttering
- NEUROHK s r o
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Kutná Hora, Tsjekkia, 284 01
- Rekruttering
- Neuroterapie KH S R O
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Pilsen, Tsjekkia, 301 00
- Rekruttering
- A Shine S R O
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Prague, Tsjekkia, 100 00
- Rekruttering
- Clintrial s r o
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Prague, Tsjekkia, 160 00
- Rekruttering
- NeuropsychiatrieHK, 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 Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
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Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
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Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
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CGI-S score ≥ 4 at Screening and Baseline;
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Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;
Exclusion Criteria:
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Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
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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;
- Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
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Has a significant 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 Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;
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The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.
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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Eksperimentell: ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration |
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration |
|
Placebo komparator: Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration |
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohen-Mansfield Agitation Inventory (CMAI) total score
Tidsramme: Week 12
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The CMAI is a reliable and validated, 29-item caregiver-rating questionnaire to assess agitated behavior in elderly patients. Each item is rated on a 7-point scale of frequency, from "never" (1) to "several times an hour" (7), with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203. |
Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impression-Severity (CGI-S) Score
Tidsramme: Week 12
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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 12
|
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
Andre studie-ID-numre
- ITI-1284-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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