Clinical trial • Phase IV • Psychiatry
ITI-1284 for Psychosis associated with Alzheimer's disease
Phase IV trial of ITI-1284 for Psychosis associated with Alzheimer's disease.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Psychosis associated with Alzheimer's disease
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-01-2025
- First CTIS Authorization Date
- 12-05-2025
Trial design
Randomised, placebo (iti-1284 placebo tablets matching the 10 mg and 20 mg active tablets); compared with iti-1284 administered once daily (placebo arm matches active tablet appearance; dose per investigator flexible-dose schedule as per protocol).-controlled Phase IV trial in Bulgaria, Romania, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo (ITI-1284 placebo tablets matching the 10 mg and 20 mg active tablets); compared with ITI-1284 administered once daily (placebo arm matches active tablet appearance; dose per investigator flexible-dose schedule as per protocol).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 172
- Trial Duration For Participant
- 42
Eligibility
Recruits 172 Patients with Alzheimer’s disease/dementia are considered a vulnerable population. Consent procedures accommodate impaired capacity: if the patient is judged competent the patient provides signed informed consent with acknowledgement from a representative/surrogate; if not competent, consent may be provided by an appropriate person (eg, legally authorized representative) in accordance with local regulations, with the patient's assent if capable or absence of dissent. Study documentation includes caregiver information, caregiver ICFs, and assent forms in multiple languages..
- Vulnerable Population
- Patients with Alzheimer’s disease/dementia are considered a vulnerable population. Consent procedures accommodate impaired capacity: if the patient is judged competent the patient provides signed informed consent with acknowledgement from a representative/surrogate; if not competent, consent may be provided by an appropriate person (eg, legally authorized representative) in accordance with local regulations, with the patient's assent if capable or absence of dissent. Study documentation includes caregiver information, caregiver ICFs, and assent forms in multiple languages.
Inclusion criteria
- {"criterion_text":"- Able to provide consent before the initiation of any study-specific procedures as follows: o If patient is deemed competent to provide informed consent in the judgement of the Investigator, can understand the nature of the trial and protocol requirements and provide signed informed consent in conjunction with an acknowledgment from the patient’s representative or surrogate (eg, caregiver, family member, friend, partner, Legally Authorized Representative [LAR]); or o If patient is deemed not competent to provide informed consent, with the patient’s assent (if capable) or lack of dissent, consent may be provided by an appropriate person (eg, patient's LAR) in accordance with local regulations.\n- Male or female, ≥ 55 years of age\n- Has a body mass index (BMI) of 18–40 kg/m2 inclusive\n- Meets clinical criteria for AD based on 2011 NIA-AAdementia criteria and biomarker criteria (Jack et al, 2018; Jack et al, 2024) which is either: o Confirmation of high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker (plasma amyloid beta 42 [Aβ42]/40 ratio and phosphorylated-tau217 [p-tau217]/non-phosphorylated-tau217 [p-tau217 ratio], or plasma Aβ42 and Aβ40 concentrations and determination of the presence of apolipoprotein E [ApoE]-specific peptides) at Screening (Visit 1); or o Confirmation of AD by historical documentation of cerebrospinal fluid (CSF) biomarker (CSF Aβ42/40, CSF p-tau181/Aβ42, or CSF total-tau/Aβ42) or amyloid positron emission tomography (PET) brain scan\n- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening (Visit 1) and Baseline (Visit 2): o Symptom(s) of psychosis were not present prior to the onset of the symptoms of AD-related dementia; to be substantiated by medical records and/or external contacts (eg, physician, family member, professional caregiver); o Symptom(s) of psychosis have been present, at least intermittently, for ≥ 1 month; o Symptoms are severe enough to cause disruption in patients’ and/or others’ ability to accomplish activities of daily functioning;\n- 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\n- CGI-S score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)\n- Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening (Visit 1) with sufficient verbal ability to understand and answer questions and comply with procedures\n- Lives at home or in an assisted living/long-term care facility and has the ability to visit the clinic as an outpatient if the study is not otherwise being conducted at the assisted living or long-term care facility. o Patients living at home must not live alone. o Patients must have been at their current location for at least 4 weeks prior to Screening (Visit 1) and plan to remain at the same location for the duration of the trial"}
Exclusion criteria
- {"criterion_text":"- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions: o Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer’s dementia; o Bipolar disorder\n- 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 (Visit 1)\n- The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients\n- The patient is receiving cholinesterase inhibitors, memantine, and/or antidepressant therapy initiated less than 8 weeks of Screening (Visit 1)\n- The patient has used 1 of the following under the specified conditions: o any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor or any CYP3A4 inducer within 5 half-lives or 14 days prior to Baseline (Visit 2), whichever is longer; o Monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2)\n- 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. See Section 7.7.2 for additional information\n- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia (skilled nursing care includes procedures that can only be administered by a registered nurse or doctor, such as [but not limited to] need for feeding tube, intravenous administration of medication, procedures related to insertion or care of suprapubic catheters, and nasopharyngeal/tracheostomy aspiration)\n- The patient is bedridden or has any significant medical condition that is unstable and that would either: o Place the patient at undue risk from study drug or undergoing study procedures; or o Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study\n- The patient is in hospice or end-of-life care"}
Endpoints
Primary endpoints
- {"endpoint_text":"- the change from baseline to end of Week 6 in BEHAVE-AD psychosis subscale score","definition_or_measurement_approach":"Change from baseline to end of Week 6 in the BEHAVE-AD psychosis subscale score (behavioral assessment instrument)."}
Secondary endpoints
- {"endpoint_text":"- the change from baseline to end of Week 6 in CGI-S score","definition_or_measurement_approach":"Change from baseline to end of Week 6 in Clinical Global Impression-Severity (CGI-S) score."}
Recruitment
- Planned Sample Size
- 172
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent is obtained from the patient if deemed competent by the Investigator; that consent is signed and accompanied by acknowledgement from the patient’s representative/surrogate. If the patient is not competent, consent may be provided by an appropriate person (eg, legally authorized representative) in accordance with local regulations, with the patient's assent if capable or absence of dissent. Study-specific informed consent and assent documents are available for patients, caregivers, study partners, and pregnant partners; consent/ICF documents and assent forms are provided in multiple languages (English, Bulgarian, Romanian, Czech, Spanish, Polish, Slovak, Croatian, Italian and others as per country-specific documents).
Methods
- Site-based recruitment at participating hospitals/clinics (country-specific trial sites listed in Part II).
- Patient brochures (country- and language-specific patient brochure documents: EN, ES, PL, RO, CZ, SK, HR, IT, BG etc.).
- Caregiver brochures (country- and language-specific caregiver brochure documents).
- Doctor-to-Patient letters (country-specific doctor-to-patient recruitment letters).
- Recruitment procedures / K1_Recruitment arrangements document (site recruitment procedures and materials).
- Patient ID cards and other participant-facing materials provided to prospective participants/caregivers.
Geography
- Total Number Of Sites
- 48
- Total Number Of Participants
- 216
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 23-04-2025
- Latest Decision Or Authorization Date
- 14-05-2025
- Processing Time Days
- 21
- Number Of Sites
- 9
- Number Of Participants
- 35
Sites
- Site Name
- Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
- Principal Investigator Name
- Petya Dimitrova
- Principal Investigator Email
- drdimitrova@abv.bg
- Contact Person Name
- Petya Dimitrova
- Contact Person Email
- drdimitrova@abv.bg
- Site Name
- Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
- Principal Investigator Name
- Ivo Natsov
- Principal Investigator Email
- ivo_nacov@abv.bg
- Contact Person Name
- Ivo Natsov
- Contact Person Email
- ivo_nacov@abv.bg
- Site Name
- Medical Center Intermedica Ltd.
- Principal Investigator Name
- Toni Donchev
- Principal Investigator Email
- tonyd@abv.bg
- Contact Person Name
- Toni Donchev
- Contact Person Email
- tonyd@abv.bg
- Site Name
- Center For Mental Health Prof. N. Shipkovenski EOOD
- Department Name
- Department “Daily stationary”, Floor 6, offices 11, 12 and 13
- Principal Investigator Name
- Ana Popova
- Principal Investigator Email
- dr.anapopova@gmail.com
- Contact Person Name
- Ana Popova
- Contact Person Email
- dr.anapopova@gmail.com
- Site Name
- Medical Center Sv.Dimitar Blagoevgrad OOD
- Principal Investigator Name
- Assen Karadaliev
- Principal Investigator Email
- karadaliev@hotmail.com
- Contact Person Name
- Assen Karadaliev
- Contact Person Email
- karadaliev@hotmail.com
- Site Name
- Medical Center Hera EOOD
- Principal Investigator Name
- Spiridon Spiridonov
- Principal Investigator Email
- spiridon.aleksiev@gmail.com
- Contact Person Name
- Spiridon Spiridonov
- Contact Person Email
- spiridon.aleksiev@gmail.com
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Department of General Psychiatry
- Principal Investigator Name
- Nadya Ivanova
- Principal Investigator Email
- nadia_odpzs@abv.bg
- Contact Person Name
- Nadya Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Department of Psychiatry
- Principal Investigator Name
- Georgi Panov
- Principal Investigator Email
- dr.georgi.panov@gmail.com
- Contact Person Name
- Georgi Panov
- Contact Person Email
- dr.georgi.panov@gmail.com
- Site Name
- Medical Center Sv.Dimitar Blagoevgrad OOD (additional site entry appears in list)
Romania
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 105
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Psihiatrie
- Principal Investigator Name
- Octavian Vasiliu
- Principal Investigator Email
- octavvasiliu@yahoo.com
- Contact Person Name
- Octavian Vasiliu
- Contact Person Email
- octavvasiliu@yahoo.com
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Psihiatrie
- Principal Investigator Name
- Traian Barbu
- Principal Investigator Email
- trabar98@yahoo.com
- Contact Person Name
- Traian Barbu
- Contact Person Email
- trabar98@yahoo.com
- Site Name
- Spitalul De Psihiatrie 'Elisabeta Doamna' Galati
- Department Name
- Psihiatrie II
- Principal Investigator Name
- Mihai Mutica
- Principal Investigator Email
- mutical@yahoo.com
- Contact Person Name
- Mihai Mutica
- Contact Person Email
- mutical@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Mental Health Center
- Principal Investigator Name
- Mihaela Rosca
- Principal Investigator Email
- mihaelarosca@gmail.com
- Contact Person Name
- Mihaela Rosca
- Contact Person Email
- mihaelarosca@gmail.com
- Site Name
- Carpe Diem S.R.L.
- Department Name
- Psihiatrie III
- Principal Investigator Name
- Cosmina Muntean
- Principal Investigator Email
- 97cosmina@gmail.com
- Contact Person Name
- Cosmina Muntean
- Contact Person Email
- 97cosmina@gmail.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (second site address)
- Department Name
- 9th Department Clinical Psychiatry
- Principal Investigator Name
- Adela Ciobanu
- Principal Investigator Email
- adela.ciobanu@yahoo.com
- Contact Person Name
- Adela Ciobanu
- Contact Person Email
- adela.ciobanu@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional site entry)
Spain
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 16-05-2025
- Processing Time Days
- 53
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Geriatria
- Principal Investigator Name
- Pedro Abizanda Soler
- Principal Investigator Email
- pabizanda@sescam.jccm.es
- Contact Person Name
- Pedro Abizanda Soler
- Contact Person Email
- pabizanda@sescam.jccm.es
- Site Name
- Clinica De Neurociencias Imbrain S.L.P.
- Department Name
- Neurología
- Principal Investigator Name
- Jesus Manuel Romero Imbroda
- Principal Investigator Email
- jesusromeroimbroda@medicalimbrain.com
- Contact Person Name
- Jesus Manuel Romero Imbroda
- Contact Person Email
- jesusromeroimbroda@medicalimbrain.com
- Site Name
- Complejo Asistencial De Zamora Hospital Provincial De Zamora
- Department Name
- Psiquiatría
- Principal Investigator Name
- Manuel Angel Franco Martin
- Principal Investigator Email
- mfrancom@saludcastillayleon.es
- Contact Person Name
- Manuel Angel Franco Martin
- Contact Person Email
- mfrancom@saludcastillayleon.es
- Site Name
- Clinica Montecanal S.L.
- Department Name
- Psiquiatría
- Principal Investigator Name
- Antonio Oliveros Cid
- Principal Investigator Email
- aoliverosc.neuropolis@gmail.com
- Contact Person Name
- Antonio Oliveros Cid
- Contact Person Email
- aoliverosc.neuropolis@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neurología
- Principal Investigator Name
- Ana Frank García
- Principal Investigator Email
- ana.frank@salud.madrid.org
- Contact Person Name
- Ana Frank García
- Contact Person Email
- ana.frank@salud.madrid.org
- Site Name
- Hospital Universitario De Getafe
- Department Name
- Geriatría
- Principal Investigator Name
- Leocadio Rodriguez Manas
- Principal Investigator Email
- leocadio.rodriguez@salud.madrid.org
- Contact Person Name
- Leocadio Rodriguez Manas
- Contact Person Email
- leocadio.rodriguez@salud.madrid.org
- Site Name
- Hospital Universitario De Getafe (additional entry)
Poland
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Przychodnia Srodmiescie Sp. z o.o.
- Principal Investigator Name
- Izabela Fadel
- Principal Investigator Email
- iza07@o2.pl
- Contact Person Name
- Izabela Fadel
- Contact Person Email
- iza07@o2.pl
- Site Name
- Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych UM Ośrodek Alzhaimerowski Sp. z o.o.
- Department Name
- Ośrodek Alzhaimerowski w Ścinawie
- Principal Investigator Name
- Izabela Winkel
- Principal Investigator Email
- izabelawinkel@wp.pl
- Contact Person Name
- Izabela Winkel
- Contact Person Email
- izabelawinkel@wp.pl
- Site Name
- Neuro-Care Sp. z o.o. sp.k.
- Principal Investigator Name
- Gabriela Kłodowska
- Principal Investigator Email
- g.klodowska@neuro-care.pl
- Contact Person Name
- Gabriela Kłodowska
- Contact Person Email
- g.klodowska@neuro-care.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 12-05-2025
- Processing Time Days
- 31
- Number Of Sites
- 9
- Number Of Participants
- 25
Sites
- Site Name
- Crystal Comfort s.r.o.
- Department Name
- Psychiatricka ambulancia
- Principal Investigator Name
- Dagmar Breznoscakova
- Principal Investigator Email
- dbreznoscakova@gmail.com
- Contact Person Name
- Dagmar Breznoscakova
- Contact Person Email
- dbreznoscakova@gmail.com
- Site Name
- MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
- Department Name
- Neurologicka ambulancia
- Principal Investigator Name
- Beata Dupejova
- Principal Investigator Email
- dupejova@gmail.com
- Contact Person Name
- Beata Dupejova
- Contact Person Email
- dupejova@gmail.com
- Site Name
- Epamed s.r.o.
- Department Name
- Psychiatricka ambulancia, Site Address: Hlavna 68, 040 01 Kosice
- Principal Investigator Name
- Eva Palova
- Principal Investigator Email
- epamed.ke@gmail.com
- Contact Person Name
- Eva Palova
- Contact Person Email
- epamed.ke@gmail.com
- Site Name
- Centrum Zdravia R.B.K. s.r.o.
- Department Name
- Psychiatricka ambulancia, Site Address: MUDr. Pribulu 463/15, 089 01 Svidnik
- Principal Investigator Name
- Rastislav Korba
- Principal Investigator Email
- rastislav.korba@gmail.com
- Contact Person Name
- Rastislav Korba
- Contact Person Email
- rastislav.korba@gmail.com
- Site Name
- University Hospital Bratislava
- Department Name
- Nemocnica Stare Mesto, I. neurologicka klinika LF UK a UNB
- Principal Investigator Name
- Peter Turcani
- Principal Investigator Email
- turcani1@gmail.com
- Contact Person Name
- Peter Turcani
- Contact Person Email
- turcani1@gmail.com
- Site Name
- Neures s.r.o.
- Department Name
- Neurologicka ambulancia
- Principal Investigator Name
- Renata Smikova
- Principal Investigator Email
- renata.smikova@gmail.com
- Contact Person Name
- Renata Smikova
- Contact Person Email
- renata.smikova@gmail.com
- Site Name
- Univerzitna nemocnica L. Pasteura Kosice
- Department Name
- II. Psychiatricka klinika
- Principal Investigator Name
- Slavka Dubinska
- Principal Investigator Email
- slavka.dubinska@unlp.sk
- Contact Person Name
- Slavka Dubinska
- Contact Person Email
- slavka.dubinska@unlp.sk
- Site Name
- Epamed s.r.o. (additional entry)
- Site Name
- Centrum Zdravia R.B.K. s.r.o. (additional entry)
Croatia
- Earliest CTIS Part Ii Submission Date
- 02-05-2025
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- KBC Zagreb
- Department Name
- Neurology
- Principal Investigator Name
- Fran Borovecki
- Principal Investigator Email
- fbor@mef.hr
- Contact Person Name
- Fran Borovecki
- Contact Person Email
- fbor@mef.hr
- Site Name
- Poliklinika Neuron
- Department Name
- Psychiatry
- Principal Investigator Name
- Neven Henigsberg
- Principal Investigator Email
- neven.henigsberg@zg.ht.hr
- Contact Person Name
- Neven Henigsberg
- Contact Person Email
- neven.henigsberg@zg.ht.hr
- Site Name
- Klinika za psihijatriju Vrapce
- Department Name
- Psychiatry
- Principal Investigator Name
- Ninoslav Mimica
- Principal Investigator Email
- bolnica@bolnica-vrapce.hr
- Contact Person Name
- Ninoslav Mimica
- Contact Person Email
- bolnica@bolnica-vrapce.hr
- Site Name
- KBC Zagreb (additional entry)
- Department Name
- Neurology
- Principal Investigator Name
- Natasa Klepac
- Principal Investigator Email
- natasaklepac@gmail.com
- Contact Person Name
- Natasa Klepac
- Contact Person Email
- natasaklepac@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 9
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Pia Fondazione Di Culto E Religione Card G Panico
- Department Name
- U.O. Malattie Neurodegenerative
- Principal Investigator Name
- Giancarlo Logroscino
- Principal Investigator Email
- giancarlo.logroscino@uniba.it
- Contact Person Name
- Giancarlo Logroscino
- Contact Person Email
- giancarlo.logroscino@uniba.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- U.O.C. Neurologia
- Principal Investigator Name
- Michela Marcon
- Principal Investigator Email
- michela.marcon@aulss8.veneto.it
- Contact Person Name
- Michela Marcon
- Contact Person Email
- michela.marcon@aulss8.veneto.it
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- U.O.C. CLINICA NEUROLOGICA
- Principal Investigator Name
- Paolo Barone
- Principal Investigator Email
- barone.cemand@gmail.com
- Contact Person Name
- Paolo Barone
- Contact Person Email
- barone.cemand@gmail.com
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- S.C. NEUROLOGIA
- Principal Investigator Name
- Salvatore Caratozzolo
- Principal Investigator Email
- salvatore.caratozzolo@hotmail.com
- Contact Person Name
- Salvatore Caratozzolo
- Contact Person Email
- salvatore.caratozzolo@hotmail.com
- Site Name
- Fondazione Istituto G. Giglio Di Cafalu
- Department Name
- U.O. Neurologia
- Principal Investigator Name
- Luigi Grimaldi
- Principal Investigator Email
- luigi.grimaldi@hsrgiglio.it
- Contact Person Name
- Luigi Grimaldi
- Contact Person Email
- luigi.grimaldi@hsrgiglio.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 192
- Number Of Sites
- 4
- Number Of Participants
- 34
Sites
- Site Name
- Neurohk s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Martin Vališ
- Principal Investigator Email
- valismar@seznam.cz
- Contact Person Name
- Martin Vališ
- Contact Person Email
- valismar@seznam.cz
- Site Name
- Neuro Health Centrum s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Kateřina Sheardová
- Principal Investigator Email
- ksheardova@gmail.com
- Contact Person Name
- Kateřina Sheardová
- Contact Person Email
- ksheardova@gmail.com
- Site Name
- INEP medical s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Alexander Nawka
- Principal Investigator Email
- clinicaltrials@inep.cz
- Contact Person Name
- Alexander Nawka
- Contact Person Email
- clinicaltrials@inep.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Neurology
- Principal Investigator Name
- Martina Mračková
- Principal Investigator Email
- martina.mrackova@fnusa.cz
- Contact Person Name
- Martina Mračková
- Contact Person Email
- martina.mrackova@fnusa.cz
Sponsor
Primary sponsor
- Full Name
- Intra-Cellular Therapies Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Rater Training, Scale Delivery, Scale licensure and Rater Oversight and Interventions Services; plus multiple sponsor duty codes (1,2,3,4,5,6,8,12,13,15) as listed
- Name
- PPD Development LP
- Responsibilities
- PK testing; sponsorDuties code 4
- Name
- Medidata Solutions Inc.
- Responsibilities
- Sponsor duties code 7
- Name
- Propharma Group LLC
- Responsibilities
- Sponsor duties code 8
- Name
- Catalent Germany Schorndorf GmbH
- Responsibilities
- Sponsor duties code 14
- Name
- Greenphire LLC
- Responsibilities
- Reimbursement
- Name
- Cerba
- Responsibilities
- Ethanol testing (EU) and sponsor duties code 4
- Name
- C2n Diagnostics LLC
- Responsibilities
- AD Biomarker testing and sponsor duties code 4
- Name
- Q Squared Solutions Limited
- Responsibilities
- Sponsor duties code 4
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,13,15 (Other Duties description: Rater Training, Scale Delivery, Scale licensure and Rater Oversight and Interventions Services),2,3,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 15, value: Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Cerba","duties_or_roles":"sponsorDuties codes: 15 (value: Ethanol testing (EU)),4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 15 (value: PK testing),4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"C2n Diagnostics LLC","duties_or_roles":"sponsorDuties codes: 15 (value: AD Biomarker testing),4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ITI-1284
- Active Substance
- ITI-1284
- Modality
- Small molecule
- Routes Of Administration
- SUBLINGUAL USE
- Route
- Sublingual
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Dose Levels
- 10 mg | 20 mg
- Frequency
- Once daily
- Maximum Dose
- 20 mg
- Investigational Product Name
- ITI-1284 placebo tablets are yellow to off-yellow-cream, circular, freeze-dried units, debossed with a diamond matching the active tablets. The placebo matches both the 10 mg and 20 mg active tablet.
- Modality
- Other
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