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A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

StatusRecruiting
PhasePhase 2
Started2024-08-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 2027 → Sep 30, 2028
See other at-risk trials from Intra-Cellular Therapies, Inc.

Amendment history

2026-08-27
Study Identification, Study Status, Study Description, Conditions, Eligibility, Contacts/Locations v7
Study sites65→67
Eligibility criteria+43 characters
[...] udy-specific procedures in accordance with local regulations; Meets clinical criteria for AD based on 2011 NIA-AA criteri [...] 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 flui [...] ker or amyloid positron emission tomography (PET) brain scan; Meets criteria for psychosis in accordance with the Interna [...] ) provisional consensus definition at Screening and Baseline; Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid a [...] ions item (ie, psychosis subscale) at Screening and Baseline; CGI-S sc [...] [...]
Study description-422 characters
The study will be conducted in 3 periods: Screening Period (up to 4 weeks) during which patient eligibility will be assessed; Double-blind Treatment Period (6 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo; Safety Follow-up Period (30 days) d [...]
2026-07-30
Study Status, Contacts/Locations v6
Study sitesdetails revised at 3 of 65 sites
2026-07-22
Study Identification, Study Status, Contacts/Locations v5
Study sitesdetails revised at 2 of 65 sites
2026-07-02
Study Status, Contacts/Locations v4
Primary completion pushed: 2027-09 → 2028-09-30
Completion pushed: 2027-10 → 2028-12-29
Study sites65 entries, revised
Advanced Research Center, Inc Pharmacology Research Institute Wr Pri Llc ATP Clinical SiteResearch Sunwise Clinical Research Envision Trials LLC Clinical SiteResearch of Brandon Healthcare Innovations Institute Inc Brain Matters Research Science Connections LLC Homestead Associates in Research Inc K2 Medical Research Wellness Research Center Ocean Blue Medical Research Center Inc. Allied Biomedical Research Institute (ABRI), Inc South Florida Research Ph [...] Clinical SiteCenter Dr Dragisa Misovic Dedinje Special Hospital for Psychiatric Diseases Kovin University Clinical SiteCenter Kragujevac Univ [...] [...]
2026-01-12
Study Status, Contacts/Locations v3
Study sites16→65
Show 2 earlier versions
2025-02-19
Study Status, Contacts/Locations v2
Study sites13→16
2024-10-18
Study Status, Contacts/Locations v1
Start dateestimated 2024-08→confirmed 2024-08-15
Study sitesdetails revised at 7 of 13 sites
2024-08-02
Original filing
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.
Trial Details
NCT Number NCT06540833
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Psychotic Disorders, Alzheimer Disease
Enrollment 370 participants
Start Date 2024-08-15
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-29