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

Part of paid clinical trials in Anaheim, California.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06540833
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ITI-1284 — DRUG
    ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
  • Placebo — DRUG
    Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
370 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ITI-1284
  • Placebo Comparator: Placebo

Primary Outcome Measure

BEHAVE-AD psychosis subscale score [ Time Frame: Week 6 ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Clinical SiteAnaheimCalifornia92805-
Clinical SiteCosta MesaCalifornia92626-
Clinical SiteLafayetteCalifornia94549-
Clinical SiteLos AlamitosCalifornia90720-
Clinical SiteNewport BeachCalifornia92660-
Clinical SiteOrangeCalifornia92866-
Clinical SiteBonita SpringsFlorida34134-
Clinical SiteBrandonFlorida33511-
Clinical SiteCoral SpringsFlorida33067-
Clinical SiteDelray BeachFlorida33445-
Clinical SiteDoralFlorida33178-
Clinical SiteHomesteadFlorida33033-
Clinical SiteMaitlandFlorida32751-
Clinical SiteMiamiFlorida33135-
Clinical SiteMiamiFlorida33144-
Clinical SiteMiamiFlorida33155-
Clinical SiteMiamiFlorida33166-
Clinical SiteMiamiFlorida33186-
Clinical SiteOrlandoFlorida32803-
Clinical SiteSarasotaFlorida34239-
Clinical SiteTampaFlorida33613-
Clinical SiteTampaFlorida33614-
Clinical SiteToms RiverNew Jersey08755-
Clinical SiteCharlotteNorth Carolina28211-
Clinical SiteCypressTexas77429-
Clinical SiteSan AntonioTexas78229-
Clinical SiteBellevueWashington98007-

Find similar trials in Anaheim, CA

By research site
Clinical Site· Anaheim, CAClinical Site· Costa Mesa, CAClinical Site· Lafayette, CAClinical Site· Los Alamitos, CAClinical Site· Newport Beach, CAClinical Site· Orange, CA

Related Studies