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A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Led by Intra-Cellular Therapies, Inc. · Updated on 2026-01-12
320
Participants Needed
69
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Can understand the trial and provide signed informed consent, or have a legally authorized representative provide consent with patient's assent if needed
- Meets clinical criteria for Alzheimer's disease based on 2011 NIA-AA dementia and biomarker criteria
- Has confirmed amyloid pathology by blood biomarker or historical CSF biomarker or amyloid PET brain scan
- Meets agitation criteria according to the International Psychogeriatric Association consensus definition
- Has clinically meaningful agitation with NPI-AA domain total score 4 at Screening and Baseline
- Has a CGI-S score 4 at Screening and Baseline
- Has a Mini-Mental State Examination 2nd Edition: Standard Version (MMSE-2�ae:SV) score between 6 and 24 at Screening
You will not qualify if you...
- Agitation symptoms caused by medications, environmental factors, substance abuse, or active medical or 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 imminent danger to self or others, or history of suicide attempts within 2 years before Screening
- Known hypersensitivity or intolerance to ITI-1284, lumateperone, or any excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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