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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

StatusRecruiting
PhasePhase 2
Started2024-10-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 58 days later Oct 2027 → Dec 28, 2027
See other at-risk trials from Intra-Cellular Therapies, Inc.

Amendment history

2026-08-24
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v8
Eligibility criteria+47 characters
[...] disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or Has historical documentation of cerebrospinal fluid (CS [...]
Study description-423 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 (12 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) [...]
Study sitesdetails revised at 5 of 70 sites
2026-07-30
Study Status v7
Re-verified, no change to tracked fields
2026-07-22
Study Identification, Study Status, Contacts/Locations v6
Study sites70 entries, revised
SFM Clinical Research LLC
2026-07-02
Study Status, Contacts/Locations v5
Primary completion pushed: 2027-10 → 2027-12-28
Completion pushed: 2027-11 → 2027-12-28
Study sites69→70
2026-01-09
Study Status, Eligibility, Contacts/Locations v4
Study sites17→69
Eligibility criteria-1 characters
[...] ional Psychogeriatric Association (IPA) consensus definition: Has clinically meaningful agitation defined as a Neuropsych [...]
Show 3 earlier versions
2025-02-19
Study Status, Contacts/Locations v3
Start dateestimated 2024-10→confirmed 2024-10-22
Study sitesdetails revised at 1 of 17 sites
2024-10-22
Study Identification, Study Status v2
Study titlerevised
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of PsychosisAgitation Associated With Alzheimer's Dementia
2024-10-21
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+88 characters
[...] ordance with local regulations; Meets clinical criteria for ADAlzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either: Has a high likelihood for amyloid pathology consistent with ADAlzheimer's disease, as confirmed by blood-based biomarker at Screening; or Has [...]
Secondary endpoints1 entry, revised
Clinical Global Impression-Severity (CGI-S) Score
2024-10-18
Original filing
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.
Trial Details
NCT Number NCT06651567
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Agitation Associated With Alzheimer's Dementia
Enrollment 320 participants
Start Date 2024-10-22
Primary Completion 2027-12-28 (estimated)
Study Completion 2027-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-29