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En undersøgelse for at vurdere effektiviteten og sikkerheden af ​​ITI-1284 i behandlingen af ​​psykose forbundet med Alzheimers demens

2. november 2026 opdateret af: Intra-Cellular Therapies, Inc.

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

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

320

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Lovech, Bulgarien, 5500
        • Rekruttering
        • State Psychiatric Hospital - Lovech
      • Pleven, Bulgarien, 5800
        • Rekruttering
        • Medical Center Medconsult-Pleven
      • Sofia, Bulgarien, 1680
        • Rekruttering
        • Medical Center Intermedica, OOD
      • Sofia, Bulgarien, 1408
        • Rekruttering
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgarien, 1510
        • Rekruttering
        • Medical Center Hera EOOD
      • Sofia, Bulgarien, 1377
        • Rekruttering
        • Mental Health Centre Prof. N Shipkovenski EOOD
      • Stara Zagora, Bulgarien, 6003
        • Rekruttering
        • UMHAT Prof. Dr. St. Kirkovich AD
    • California
      • Anaheim, California, Forenede Stater, 92805
        • Rekruttering
        • Advanced Research Center, Inc
      • Costa Mesa, California, Forenede Stater, 92626
        • Afsluttet
        • ATP Clinical Research
      • Garden Grove, California, Forenede Stater, 92844
        • Afsluttet
        • National Institute Of Clinical Research
      • Newport Beach, California, Forenede Stater, 92660
        • Afsluttet
        • Wr Pri Llc
      • Walnut Creek, California, Forenede Stater, 94596
        • Rekruttering
        • Sunwise Clinical Research
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33487
        • Rekruttering
        • SFM Clinical Research LLC
      • Bonita Springs, Florida, Forenede Stater, 34134
        • Rekruttering
        • Envision Trials LLC
      • Brandon, Florida, Forenede Stater, 33511
        • Rekruttering
        • Clinical Research of Brandon
      • Delray Beach, Florida, Forenede Stater, 33445
        • Afsluttet
        • Brain Matters Research
      • Doral, Florida, Forenede Stater, 33178
        • Rekruttering
        • Science Connections LLC
      • Hialeah, Florida, Forenede Stater, 33012-3618
        • Rekruttering
        • Direct Helpers Medical Center, Inc.
      • Homestead, Florida, Forenede Stater, 33033
        • Rekruttering
        • Homestead Associates in Research Inc
      • Maitland, Florida, Forenede Stater, 32751
        • Rekruttering
        • K2 Medical Research
      • Maitland, Florida, Forenede Stater, 32751
        • Rekruttering
        • Neurology Associates PA
      • Miami, Florida, Forenede Stater, 33155-4630
        • Rekruttering
        • Allied Biomedical Research Institute (ABRI), Inc
      • Miami, Florida, Forenede Stater, 33122
        • Rekruttering
        • Vital Care Research
      • Miami, Florida, Forenede Stater, 33135
        • Rekruttering
        • Wellness Research Center
      • Miami, Florida, Forenede Stater, 33135
        • Rekruttering
        • Advanced Clinical Research Network
      • Miami, Florida, Forenede Stater, 33166
        • Rekruttering
        • South Florida Research Phase I-IV
      • Miami, Florida, Forenede Stater, 33135
        • Suspenderet
        • Advance Medical Research Center
      • Miami, Florida, Forenede Stater, 33186
        • Rekruttering
        • Sunshine Medical Research Studies Inc
      • Miami, Florida, Forenede Stater, 33180
        • Afsluttet
        • Miami Jewish Health System
      • Orlando, Florida, Forenede Stater, 32803
        • Rekruttering
        • Charter Research
      • Orlando, Florida, Forenede Stater, 32807
        • Afsluttet
        • Combined Research Orlando
      • Tampa, Florida, Forenede Stater, 33614
        • Rekruttering
        • Psych Me Medical Research Inc
      • Tampa, Florida, Forenede Stater, 33614
        • Rekruttering
        • Quantum Research Associates Corp
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Rekruttering
        • Premiere Research Institute at Palm Beach Neurology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Rekruttering
        • Tufts University School of Medicine
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89121
        • Rekruttering
        • Oasis Clinical Research LLC
    • New Jersey
      • Toms River, New Jersey, Forenede Stater, 08755
        • Rekruttering
        • Bio Behavioral Health
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Afsluttet
        • Eximia Clinical Research NC
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • UT Health San Antonio
      • Zagreb, Kroatien, 10000
        • Rekruttering
        • University Hospital Centre Zagreb
      • Zagreb, Kroatien, 10000
        • Afsluttet
        • University Hospital Centre Zagreb 1
      • Zagreb, Kroatien, 10090
        • Rekruttering
        • Psychiatric Clinic "VRAPCE"
      • Zagreb, Kroatien, 10090
        • Rekruttering
        • Psychiatric Hospital Sveti Ivan
      • Bucharest, Rumænien, 041914
        • Rekruttering
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
      • Bucharest, Rumænien, 010825
        • Rekruttering
        • Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
      • Bucharest, Rumænien, 040874
        • Rekruttering
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
      • Bucharest, Rumænien, 60222
        • Rekruttering
        • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
      • Com Sanpetru, Rumænien, 507190
        • Rekruttering
        • Spitalul de Psihiatrie si Neurologie Brasov
      • Sibiu, Rumænien, 550281
        • Rekruttering
        • SC Carpe Diem SRL
      • Belgrade, Serbien, 11000
        • Rekruttering
        • Institute of Mental Health Serbia
      • Belgrade, Serbien, 11000
        • Rekruttering
        • Clinical Center Dr Dragisa Misovic Dedinje
      • Kovin, Serbien, 26220
        • Afsluttet
        • Special Hospital for Psychiatric Diseases Kovin
      • Niš, Serbien, 18000
        • Rekruttering
        • University Clinical Center NIS
      • Novi Kneževac, Serbien, 23330
        • Suspenderet
        • Special Hospital for Psychiatric Diseases Sveti Vracevi
      • Banská Bystrica, Slovakiet, 97404
        • Rekruttering
        • Neurologicka ambulancia MUDr.Dupejova s.r.o.
      • Bratislava, Slovakiet, 81369
        • Rekruttering
        • Univerzitna nemocnica Bratislava
      • Košice, Slovakiet, 4001
        • Rekruttering
        • Epamed sro
      • Krompachy, Slovakiet, 05342
        • Rekruttering
        • NEURES s r o
      • Svidník, Slovakiet, 089 01
        • Rekruttering
        • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
      • Vranov nad Topľou, Slovakiet, 09301
        • Rekruttering
        • Crystal Comfort s.r.o.
      • Albacete, Spanien, 02006
        • Rekruttering
        • Hosp. Gral. de Albacete
      • Badalona, Spanien, 08916
        • Rekruttering
        • Hospital Universitari Germans Trias i Pujol
      • Málaga, Spanien, 29004
        • Rekruttering
        • Hosp. Quirónsalud Málaga
      • Zamora, Spanien, 49021
        • Rekruttering
        • Hosp. Prov. de Zamora
      • Zaragoza, Spanien, 50012
        • Suspenderet
        • Hosp. Viamed Montecanal
      • Brno, Tjekkiet, 602 00
        • Rekruttering
        • Fakultni nemocnice u sv. Anny v Brne
      • Choceň, Tjekkiet, 56501
        • Rekruttering
        • NEUROHK s r o
      • Kutná Hora, Tjekkiet, 284 01
        • Rekruttering
        • Neuroterapie KH S R O
      • Pilsen, Tjekkiet, 301 00
        • Rekruttering
        • A Shine S R O
      • Prague, Tjekkiet, 100 00
        • Rekruttering
        • Clintrial s r o
      • Prague, Tjekkiet, 160 00
        • Rekruttering
        • NeuropsychiatrieHK, s.r.o.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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;

  • 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;
  • Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition

  • Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;

  • CGI-S score ≥ 4 at Screening and Baseline;

  • Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;

Exclusion Criteria:

  • Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;

  • 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;
  • 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;

  • The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cohen-Mansfield Agitation Inventory (CMAI) total score
Tidsramme: Week 12

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
Foranstaltningsbeskrivelse
Tidsramme
Clinical Global Impression-Severity (CGI-S) Score
Tidsramme: Week 12

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. oktober 2024

Primær færdiggørelse (Anslået)

28. december 2027

Studieafslutning (Anslået)

28. december 2027

Datoer for studieregistrering

Først indsendt

18. oktober 2024

Først indsendt, der opfyldte QC-kriterier

18. oktober 2024

Først opslået (Faktiske)

21. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ITI-1284-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .