En undersøgelse for at vurdere effektiviteten og sikkerheden af ITI-1284 i behandlingen af psykose forbundet med Alzheimers demens
En multicenter, randomiseret, dobbeltblind, placebokontrolleret, fleksibel dosisundersøgelse af effektiviteten, sikkerheden og tolerabiliteten af ITI-1284 hos patienter med agitation forbundet 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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Lovech, Bulgarien, 5500
- Rekruttering
- State Psychiatric Hospital - Lovech
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Pleven, Bulgarien, 5800
- Rekruttering
- Medical Center Medconsult-Pleven
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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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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center, Inc
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Costa Mesa, California, Forenede Stater, 92626
- Afsluttet
- ATP Clinical Research
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Garden Grove, California, Forenede Stater, 92844
- Afsluttet
- National Institute Of Clinical Research
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Newport Beach, California, Forenede Stater, 92660
- Afsluttet
- Wr Pri Llc
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Walnut Creek, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research
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Florida
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Boca Raton, Florida, Forenede Stater, 33487
- Rekruttering
- SFM Clinical Research LLC
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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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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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Hialeah, Florida, Forenede Stater, 33012-3618
- Rekruttering
- Direct Helpers Medical Center, Inc.
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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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Maitland, Florida, Forenede Stater, 32751
- Rekruttering
- Neurology Associates PA
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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, 33122
- Rekruttering
- Vital Care Research
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Wellness Research Center
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Advanced Clinical Research Network
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Miami, Florida, Forenede Stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami, Florida, Forenede Stater, 33135
- Suspenderet
- Advance Medical Research Center
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Miami, Florida, Forenede Stater, 33186
- Rekruttering
- Sunshine Medical Research Studies Inc
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Miami, Florida, Forenede Stater, 33180
- Afsluttet
- Miami Jewish Health System
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- Charter Research
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Orlando, Florida, Forenede Stater, 32807
- Afsluttet
- Combined Research Orlando
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Tampa, Florida, Forenede Stater, 33614
- Rekruttering
- Psych Me Medical Research Inc
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Tampa, Florida, Forenede Stater, 33614
- Rekruttering
- Quantum Research Associates Corp
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West Palm Beach, Florida, Forenede Stater, 33407
- Rekruttering
- Premiere Research Institute at Palm Beach Neurology
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Rekruttering
- Tufts University School of Medicine
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89121
- Rekruttering
- Oasis Clinical 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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Raleigh, North Carolina, Forenede Stater, 27607
- Afsluttet
- Eximia Clinical Research NC
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- UT Health San Antonio
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Zagreb, Kroatien, 10000
- Rekruttering
- University Hospital Centre Zagreb
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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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Zagreb, Kroatien, 10090
- Rekruttering
- Psychiatric Hospital Sveti Ivan
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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
- Rekruttering
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
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Com Sanpetru, Rumænien, 507190
- Rekruttering
- Spitalul de Psihiatrie si Neurologie Brasov
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Sibiu, Rumænien, 550281
- Rekruttering
- SC Carpe Diem SRL
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Belgrade, Serbien, 11000
- Rekruttering
- Institute of Mental Health Serbia
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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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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
- Rekruttering
- Neurologicka ambulancia MUDr.Dupejova s.r.o.
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Bratislava, Slovakiet, 81369
- Rekruttering
- Univerzitna nemocnica Bratislava
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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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Svidník, Slovakiet, 089 01
- Rekruttering
- Psychiatricka Ambulancia Centrum Zdravia R.B.K. 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
- Rekruttering
- Hosp. Gral. de Albacete
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Badalona, Spanien, 08916
- Rekruttering
- Hospital Universitari Germans Trias i Pujol
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Málaga, Spanien, 29004
- Rekruttering
- Hosp. Quirónsalud Málaga
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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, 602 00
- Rekruttering
- Fakultni nemocnice u sv. Anny v Brne
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Choceň, Tjekkiet, 56501
- Rekruttering
- NEUROHK s r o
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Kutná Hora, Tjekkiet, 284 01
- Rekruttering
- Neuroterapie KH S R O
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Pilsen, Tjekkiet, 301 00
- Rekruttering
- A Shine S R O
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Prague, Tjekkiet, 100 00
- Rekruttering
- Clintrial s r o
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Prague, Tjekkiet, 160 00
- Rekruttering
- NeuropsychiatrieHK, s.r.o.
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Deltagelseskriterier
Berettigelseskriterier
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 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ITI-1284-101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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