Actively Recruiting
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
Led by Intra-Cellular Therapies, Inc. · Updated on 2026-01-13
370
Participants Needed
65
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ITI-1284 for treating psychosis in patients with Alzheimer's disease. This multicenter, randomized, double-blind, placebo-controlled Phase 2 study aims to assess the efficacy, safety, and tolerability of ITI-1284 in comparison to a placebo. Psychosis symptoms related to Alzheimer's disease present challenges that this study seeks to address under controlled conditions. The study includes three periods: a screening phase up to 4 weeks to determine eligibility; a 6-week double-blind treatment phase where participants are randomly assigned to receive either ITI-1284 or placebo; and a 30-day safety follow-up period after the last dose to monitor participants' health. ITI-1284 is given as a 10 mg or 20 mg rapidly disintegrating tablet taken once daily under the tongue. Participants will attend study visits for assessments including psychosis symptom scoring using the BEHAVE-AD psychosis subscale and clinical global impressions at baseline and week 6. Caregivers are involved in the process, and safety monitoring continues through the follow-up visit about 30 days after treatment ends. The study's total participation time includes screening, treatment, and safety follow-up, ensuring close observation of patients throughout.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the trial and provide signed informed consent or have consent provided by a legally authorized representative
- Meets clinical criteria for Alzheimer's disease confirmed by blood-based biomarkers, cerebrospinal fluid biomarkers, or amyloid PET brain scan
- Meets criteria for psychosis based on International Psychogeriatric Association definition at screening and baseline
- Scores 2 or higher on BEHAVE-AD psychosis subscale items for paranoid/delusional ideation or hallucinations at screening and baseline
- Has a Clinical Global Impression-Severity (CGI-S) score of 4 or higher at screening and baseline
- Mini-Mental State Examination (MMSE-2:SV) score between 6 and 24 inclusive at screening with ability to comply with study procedures
- Has a designated caregiver such as a relative, housemate, close friend, or professional caretaker
You will not qualify if you...
- Psychotic symptoms primarily due to delirium, substance abuse, or other medical conditions or diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or other unrelated psychotic disorders
- Risk of suicidal behavior or recent suicide attempt within 2 years prior to screening
- Unable or unwilling to stop other drugs with psychotropic or significant central nervous system effects
- Hospitalized or receiving skilled nursing care for medical conditions other than dementia
- Bedridden or has unstable medical conditions that increase risk or interfere with study evaluations
- Currently in hospice or end-of-life care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants are randomized to receive either ITI-1284 or placebo daily for psychosis associated with Alzheimer's disease.
Daily dosing during treatment period
Duration - 30 days
Participants return for a safety follow-up visit approximately 30 days after the last dose of study drug.
1 visit (in-person) approximately 30 days after treatment ends
Trial Site Locations
Total: 65 locations
1
Clinical Site
Anaheim, California, United States, 92805
Actively Recruiting
2
Clinical Site
Costa Mesa, California, United States, 92626
Active, Not Recruiting
3
Clinical Site
Lafayette, California, United States, 94549
Not Yet Recruiting
4
Clinical Site
Los Alamitos, California, United States, 90720
Withdrawn
5
Clinical Site
Newport Beach, California, United States, 92660
Actively Recruiting
6
Clinical Site
Orange, California, United States, 92866
Actively Recruiting
7
Clinical Site
Bonita Springs, Florida, United States, 34134
Actively Recruiting
8
Clinical Site
Brandon, Florida, United States, 33511
Actively Recruiting
9
Clinical Site
Coral Springs, Florida, United States, 33067
Actively Recruiting
10
Clinical Site
Delray Beach, Florida, United States, 33445
Actively Recruiting
11
Clinical Site
Doral, Florida, United States, 33178
Actively Recruiting
12
Clinical Site
Homestead, Florida, United States, 33033
Actively Recruiting
13
Clinical Site
Maitland, Florida, United States, 32751
Actively Recruiting
14
Clinical Site
Miami, Florida, United States, 33135
Actively Recruiting
15
Clinical Site
Miami, Florida, United States, 33144
Actively Recruiting
16
Clinical Site
Miami, Florida, United States, 33155
Actively Recruiting
17
Clinical Site
Miami, Florida, United States, 33166
Actively Recruiting
18
Clinical Site
Miami, Florida, United States, 33186
Actively Recruiting
19
Clinical Site
Orlando, Florida, United States, 32803
Actively Recruiting
20
Clinical Site
Sarasota, Florida, United States, 34239
Actively Recruiting
21
Clinical Site
Tampa, Florida, United States, 33613
Actively Recruiting
22
Clinical Site
Tampa, Florida, United States, 33614
Actively Recruiting
23
Clinical Site
Toms River, New Jersey, United States, 08755
Actively Recruiting
24
Clinical Site
Charlotte, North Carolina, United States, 28211
Actively Recruiting
25
Clinical Site
Cypress, Texas, United States, 77429
Actively Recruiting
26
Clinical Site
San Antonio, Texas, United States, 78229
Actively Recruiting
27
Clinical Site
Bellevue, Washington, United States, 98007
Actively Recruiting
28
Clinical Site
Blagoevgrad, Bulgaria, 2700
Actively Recruiting
29
Clinical Site
Cherven Bryag, Bulgaria, 5980
Actively Recruiting
30
Clinical Site
Sofia, Bulgaria, 1377
Actively Recruiting
31
Clinical Site
Sofia, Bulgaria, 1408
Actively Recruiting
32
Clinical Site
Sofia, Bulgaria, 1510
Actively Recruiting
33
Clinical Site
Sofia, Bulgaria, 1680
Actively Recruiting
34
Clinical Site
Stara Zagora, Bulgaria, 6000
Actively Recruiting
35
Clinical Site
Vratsa, Bulgaria, 3000
Actively Recruiting
36
Clinical Site_2
Zagreb, Croatia, 10000
Actively Recruiting
37
Clinical Site
Zagreb, Croatia, 10000
Actively Recruiting
38
Clinical Site
Zagreb, Croatia, 10090
Actively Recruiting
39
Clinical Site
Brno, Czechia, 60200
Actively Recruiting
40
Clinical Site
Brno, Czechia, 62800
Actively Recruiting
41
Clinical Site
Hradec Králové, Czechia, 50002
Actively Recruiting
42
Clinical Site
Prague, Czechia, 18600
Actively Recruiting
43
Clinical Site
Bydgoszcz, Poland, 85-080
Actively Recruiting
44
Clinical Site
Ścinawa, Poland, 59-330
Actively Recruiting
45
Clinical Site
Bucharest, Romania, 10825
Actively Recruiting
46
Clinical Site
Bucharest, Romania, 40874
Actively Recruiting
47
Clinical Site
Bucharest, Romania, 41914
Actively Recruiting
48
Clinical Site
Bucharest, Romania, 60222
Actively Recruiting
49
Clinical Site
Galati, Romania, 800179
Actively Recruiting
50
Clinical Site
Sibiu, Romania, 550281
Actively Recruiting
51
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
52
Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
53
Clinical Site
Kragujevac, Serbia, 34000
Actively Recruiting
54
Clinical Site
Niš, Serbia, 18000
Actively Recruiting
55
Clinical Site
Novi Kneževac, Serbia, 23330
Actively Recruiting
56
Clinical Site
Banská Bystrica, Slovakia, 97404
Actively Recruiting
57
Clinical Site
Bratislava, Slovakia, 81369
Actively Recruiting
58
Clinical Site
Košice, Slovakia, 4001
Actively Recruiting
59
Clinical Site
Košice, Slovakia, 4190
Actively Recruiting
60
Clinical Site
Krompachy, Slovakia, 5342
Actively Recruiting
61
Clinical Site
Vranov nad Topľou, Slovakia, 9301
Actively Recruiting
62
Clinical Site
Albacete, Spain, 2006
Actively Recruiting
63
Clinical Site
Madrid, Spain, 28046
Not Yet Recruiting
64
Clinical Site
Zamora, Spain, 49021
Not Yet Recruiting
65
Clinical Site
Zaragoza, Spain, 50012
Actively Recruiting
Research Team
I
ITI Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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