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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
Led by Intra-Cellular Therapies, Inc. · Updated on 2026-01-12
320
Participants Needed
69
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ITI-1284 to evaluate its effects on agitation in patients with Alzheimer's dementia. This multicenter, randomized, double-blind, placebo-controlled trial aims to assess the efficacy, safety, and tolerability of ITI-1284 in this patient population. The trial includes patients aged 55 years and older who meet specific clinical and biomarker criteria for Alzheimer's disease and exhibit clinically meaningful agitation. Participants will be randomly assigned to receive either ITI-1284 or a placebo in a flexible dosing regimen of 10 mg or 20 mg once daily via sublingual rapidly disintegrating tablets. The study consists of three periods: a screening period lasting up to 4 weeks to confirm eligibility; a 12-week double-blind treatment period where patients receive the study drug or placebo; and a 30-day safety follow-up period after the last dose to monitor any adverse effects. During the trial, participants will undergo assessments including the Cohen-Mansfield Agitation Inventory (CMAI) to measure agitation levels, Clinical Global Impression-Severity (CGI-S) scoring, and cognitive testing with the Mini-Mental State Examination (MMSE-2:SV). Researchers will also monitor for safety and tolerability throughout the study. The total participation duration includes screening, treatment, and follow-up phases, allowing for comprehensive evaluation of the study drug's impact on agitation associated with Alzheimer's dementia.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the trial and provide informed consent, or have a legally authorized representative provide consent with patient assent if applicable
- Meets clinical and biomarker criteria for Alzheimer's disease
- Has a high likelihood of amyloid pathology confirmed by blood biomarker or past CSF/amyloid PET scan
- Meets agitation criteria according to International Psychogeriatric Association
- Has clinically meaningful agitation with NPI-AA score of 4 or higher at screening and baseline
- Has a Clinical Global Impression-Severity (CGI-S) score of 4 or higher at screening and baseline
- Has Mini-Mental State Examination (MMSE-2:SV) score between 6 and 24 at screening
You will not qualify if you...
- Agitation caused by other medications, environmental factors, substance abuse, or active medical/psychiatric conditions
- Diagnosed with schizophrenia, schizoaffective disorder, or other psychotic disorders unrelated to Alzheimer's dementia
- Diagnosed with bipolar disorder
- Diagnosed with major depressive disorder unless stable and treated for at least 8 weeks before screening
- Significant risk of suicidal behavior or recent suicide attempts within 2 years
- Known allergy or intolerance to ITI-1284, lumateperone, or any excipients
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.
1 visit (in-person) for screening and enrollment
Duration - 12 weeks
Participants receive either ITI-1284 or placebo once daily to assess efficacy and safety in treating agitation associated with Alzheimer's dementia.
Weekly visits for up to 12 weeks
Duration - 30 days
Participants return for a safety follow-up visit approximately 30 days after the last dose of study drug to monitor safety.
1 visit (in-person)
Trial Site Locations
Total: 69 locations
1
Clinical Site
Anaheim, California, United States, 92805
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2
Clinical Site
Costa Mesa, California, United States, 92626
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3
Clinical Site
Garden Grove, California, United States, 92844
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4
Clinical Site
Boca Raton, Florida, United States, 33487
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5
Clinical Site
Bonita Springs, Florida, United States, 34134
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6
Clinical Site
Brandon, Florida, United States, 33511
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7
Clinical Site
Delray Beach, Florida, United States, 33445
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8
Clinical Site
Doral, Florida, United States, 33178
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9
Clinical Site
Hialeah, Florida, United States, 33012
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10
Clinical Site
Homestead, Florida, United States, 33033
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11
Clinical Site_2
Maitland, Florida, United States, 32751
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12
Clinical Site
Maitland, Florida, United States, 32751
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13
Clinical Site
Miami, Florida, United States, 33122
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14
Clinical Site_2
Miami, Florida, United States, 33135
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15
Clinical Site_3
Miami, Florida, United States, 33135
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16
Clinical Site
Miami, Florida, United States, 33135
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17
Clinical Site
Miami, Florida, United States, 33137
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18
Clinical Site
Miami, Florida, United States, 33155
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19
Clinical Site
Miami, Florida, United States, 33166
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20
Clinical Site
Miami, Florida, United States, 33186
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21
Clinical Site
Orlando, Florida, United States, 32803
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22
Clinical Site
Orlando, Florida, United States, 32807
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23
Clinical Site_2
Tampa, Florida, United States, 33614
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24
Clinical Site
Tampa, Florida, United States, 33614
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25
Clinical Site
West Palm Beach, Florida, United States, 33407
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26
Clinical Site
Boston, Massachusetts, United States, 02111
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27
Clinical Site
Las Vegas, Nevada, United States, 89121
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28
Clinical Site
Toms River, New Jersey, United States, 08755
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29
Clinical Site
Raleigh, North Carolina, United States, 27607
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30
Clinical Site
San Antonio, Texas, United States, 78229
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31
Clinical Site
Lovech, Bulgaria, 5500
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32
Clinical Site
Pleven, Bulgaria, 5800
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33
Clinical Site
Sofia, Bulgaria, 1377
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34
Clinical Site
Sofia, Bulgaria, 1408
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35
Clinical Site
Sofia, Bulgaria, 1510
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36
Clinical Site
Sofia, Bulgaria, 1680
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37
Clinical Site
Stara Zagora, Bulgaria, 6000
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38
Clinical Site_2
Zagreb, Croatia, 10000
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39
Clinical Site_3
Zagreb, Croatia, 10000
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40
Clinical Site
Zagreb, Croatia, 10000
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41
Clinical Site
Zagreb, Croatia, 10090
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42
Clinical Site
Brno, Czechia, 602 00
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43
Clinical Site
Choceň, Czechia, 56501
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44
Clinical Site
Kutná Hora, Czechia, 284 01
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45
Clinical Site
Pilsen, Czechia, 30100
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46
Clinical Site
Prague, Czechia, 100 00
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47
Clinical Site
Prague, Czechia, 160 00
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48
Clinical Site
Bucharest, Romania, 010825
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49
Clinical Site
Bucharest, Romania, 040874
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50
Clinical Site
Bucharest, Romania, 041914
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51
Clinical Site
Bucharest, Romania, 060222
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52
Clinical Site
Sânpetru, Romania, 507190
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53
Clinical Site
Sibiu, Romania, 550281
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54
Clinical Site_2
Belgrade, Serbia, 11000
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55
Clinical Site
Belgrade, Serbia, 11000
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56
Clinical Site
Kovin, Serbia, 26220
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57
Clinical Site
Niš, Serbia, 18000
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58
Clinical Site
Novi Kneževac, Serbia, 23330
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59
Clinical Site
Banská Bystrica, Slovakia, 97404
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60
Clinical Site
Bratislava, Slovakia, 81369
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61
Clinical Site
Košice, Slovakia, 4001
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62
Clinical Site
Krompachy, Slovakia, 05342
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63
Clinical Site
Svidník, Slovakia, 08901
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64
Clinical Site
Vranov nad Topľou, Slovakia, 09301
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65
Clinical Site
Albacete, Spain, 02006
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66
Clinical Site
Barcelona, Spain, 08916
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67
Clinical Site
Málaga, Spain, 29004
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68
Clinical Site
Zamora, Spain, 49021
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69
Clinical Site
Zaragoza, Spain, 50012
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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
Frequently Asked Questions
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