A Phase 2 interventional study of ITI-1284 and Placebo in Agitation Associated With Alzheimer's Dementia, sponsored by Intra-Cellular Therapies, Inc.. Recruiting at 71 sites in 8 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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Among 35 studies in Dementia by Johnson & Johnson — 1 open to participants now, 1 under way, none of them phase 3. Dementia · Johnson & Johnson.
Among the 35 studies in Dementia by Johnson & Johnson, this one is the 17th largest by planned enrollment of the 26 interventional ones that give a count, is the only one that started in 2024, is one of 2 in phase 2, and was the 35th registered.
2,374 studies on the registry are indexed under Dementia; 573 are open to participants now.
Browse Dementia studies →1 of the 35 studies in Dementia by Johnson & Johnson is open now, in 8 countries.
By country, each count listing its studies:
Of the 383 Dementia studies recruiting now, 244 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 164 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 18 · Phase 4 5
First in 1995; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 320 is above the median of 90 across 1,760 interventional studies indexed under Dementia.
Median enrollment 401 across the 26 interventional studies, 970 across the 9 observational. Of the 34 that completed or were terminated, 6 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Intra-Cellular Therapies, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 35 studies in Dementia by Johnson & Johnson, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Has been diagnosed with one or more of the following psychiatric conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Drug: ITI-1284
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Drug: Placebo
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Cohen-Mansfield Agitation Inventory (CMAI) total score
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.
Time frame: Week 12
Clinical Global Impression-Severity (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)
Time frame: Week 12
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Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2027, 38 months after the start.
Of 41 industry-sponsored phase 2 interventional studies under Dementia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 38 months is above that.
Counting every sponsor, half of 83 studies reached it within 38 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Deulumateperone
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