Psychotic DisordersPhase 2NCT06540833
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
A Phase 2 study testing ITI-1284 in people with Psychotic Disorders and Alzheimer Disease, run by Intra-Cellular Therapies, Inc. at 71 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Psychotic Disorders, Alzheimer Disease
- What is being tested?
- ITI-1284
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 71 sitesin 10 countries
- Study dates
- 15 Aug 2024to 29 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
- 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
Show all 9Show fewer
- CGI-S score ≥ 4 at Screening and Baseline
- 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
- Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)
Who cannot join
- 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
- 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
- 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
- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
Show all 10Show fewer
- 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
- The patient is in hospice or end-of-life care
Trial locations and contacts
71 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
71 sites in 10 countries
United States28 sites, 19 recruiting
- Recruiting
Advanced Research Center, Inc
Anaheim, California, 92805
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
Envision Trials LLC
Bonita Springs, Florida, 34134
- Recruiting
Clinical Research of Brandon
Brandon, Florida, 33511
- Recruiting
New Hope Clinical Research
Charlotte, North Carolina, 28211
- Completed
Healthcare Innovations Institute Inc
Coral Springs, Florida, 33067
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77065
- Completed
Brain Matters Research
Delray Beach, Florida, 33445
- Recruiting
Science Connections LLC
Doral, Florida, 33178
- Recruiting
Homestead Associates in Research Inc
Homestead, Florida, 33033
- Completed
Pharmacology Research Institute
Los Alamitos, California, 90720
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
- Recruiting
AMC Research, LLC
Matthews, North Carolina, 28105
- Recruiting
Wellness Research Center
Miami, Florida, 33135
- Suspended
Ocean Blue Medical Research Center Inc.
Miami, Florida, 33144
- Recruiting
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida, 33155-4630
- Recruiting
South Florida Research Phase I-IV
Miami, Florida, 33166
- Recruiting
Sunshine Medical Solution
Miami, Florida, 33186
- Completed
Wr Pri Llc
Newport Beach, California, 92660
- Completed
ATP Clinical Research
Orange, California, 92866
- Completed
Combined Research Orlando
Orlando, Florida, 32803
- Completed
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
- Recruiting
Intercoastal Medical Group
Sarasota, Florida, 34239
- Recruiting
CenExeli Research LLC
Savannah, Georgia, 31405
- Recruiting
University of South Florida
Tampa, Florida, 33613
- Completed
Psych Me Medical Research Inc
Tampa, Florida, 33614
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
- Recruiting
Sunwise Clinical Research
Walnut Creek, California, 94596
Bulgaria8 sites, 6 recruiting
- Completed
Medical Center Sv Dimitar Blagoevgrad
Blagoevgrad, 2700
- Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
Cherven Bryag, 5980
- Recruiting
Mental Health Centre Prof. N Shipkovenski EOOD
Sofia, 1377
- Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
- Recruiting
Medical Center Hera EOOD
Sofia, 1510
- Recruiting
Medical Center Intermedica, OOD
Sofia, 1680
- Recruiting
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, 6003
- Completed
Mental Health Center - Vratsa EOOD
Vratsa, 3000
Romania6 sites, 5 recruiting
- Recruiting
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
Bucharest, 010825
- Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
Bucharest, 040874
- Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, 041914
- Completed
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
Bucharest, 60222
- Recruiting
Spitalul De Psihiatrie Elisabeta Doamna Galaţi
Galati, 800179
- Recruiting
SC Carpe Diem SRL
Sibiu, 550281
Slovakia6 sites, 4 recruiting
- Completed
Neurologicka ambulancia MUDr.Dupejova s.r.o.
Banská Bystrica, 97404
- Suspended
Univerzitna nemocnica Bratislava
Bratislava, 81369
- Recruiting
Univerzitna nemocnica L. Pasteura Kosice
Košice, 04190
- Recruiting
Epamed sro
Košice, 4001
- Recruiting
NEURES s r o
Krompachy, 05342
- Recruiting
Crystal Comfort s.r.o.
Vranov nad Topľou, 09301
Serbia5 sites, 3 recruiting
- Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, 11000
- Completed
Special Hospital for Psychiatric Diseases Kovin
Kovin, 26220
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
University Clinical Center NIS
Niš, 18000
- Suspended
Special Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
Croatia4 sites, 3 recruiting
- Recruiting
Polyclinic Neuron
Zagreb, 10000
- Completed
University Hospital Centre Zagreb 1
Zagreb, 10000
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
- Recruiting
Psychiatric Clinic "VRAPCE"
Zagreb, 10090
Czechia4 sites, 3 recruiting
- Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 60200
- Recruiting
Neuro Health Centrum s r o
Brno, 62800
- Recruiting
NEUROHK s r o
Hradec Králové, 50002
- Completed
INEP medical s.r.o.
Prague, 18600
Italy4 sites, 4 recruiting
- Recruiting
Ospedale di Arzignano
Arzignano, 36071
- Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25123
- Recruiting
Fondazione Istituto G. Giglio
Cefalù, 90015
- Recruiting
Ospedale Cardinale G. Panico
Tricase, 73039
Poland3 sites
- Completed
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, 85 080
- Completed
Neuro Care
Katowice, 40-749
- Completed
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu
Ścinawa, 59-330
Spain3 sites, 1 recruiting
- Suspended
Hosp. Gral. de Albacete
Albacete, 02006
- Recruiting
Hosp. Prov. de Zamora
Zamora, 49021
- Suspended
Hosp. Viamed Montecanal
Zaragoza, 50012
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease
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.
- Conditions
- Psychotic Disorders, Alzheimer Disease
- Being tested
- ITI-1284, Placebo
- Medical subject headings
- Psychotic Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-1284Drug
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
PlaceboDrug
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
| Study group | Role | What they receive |
|---|---|---|
| ITI-1284 | Experimental | Not described Receives: Drug: ITI-1284 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BEHAVE-AD psychosis subscale score
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.
Measured: Week 6
Secondary outcomes (1)
CGI-S score
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)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540833
- Sponsor's protocol ID
- ITI-1284-201
- Status last verified
- Nov 2026
- First submitted
- 2 Aug 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06540833
- Acronym / sponsor ID
- ITI-1284-201
- Conditions
- Psychotic Disorders, Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITI-1284 | Experimental | Drug: ITI-1284 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 AD based on 2011 NIA-AA criteria and either:
- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
- 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
- CGI-S score ≥ 4 at Screening and Baseline
Key exclusion criteria (10 listed)
- 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:
- 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
- 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
- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
- The patient is bedridden or has any significant medical condition that is unstable and would either:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-1284ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration | Drug | ITI-1284 |
| PlaceboPlacebo rapidly disintegrating tablet, taken once daily, sublingual administration | Drug | Placebo |
Primary outcome
BEHAVE-AD psychosis subscale score
Time frame: Week 6
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.
1 secondary outcome
CGI-S score
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
71 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ITI-1284 in people with Psychotic Disorders and Alzheimer Disease, run by Intra-Cellular Therapies, Inc. at 71 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Bulgaria, Romania, Slovakia, Serbia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BEHAVE-AD psychosis subscale score (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.