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
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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

First listed
Aug 6, 2024
Start date
Aug 15, 2024
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Dec 29, 2028

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 (26)

FacilityCityStateZIPSite coordinators
Advanced Research Center, IncAnaheimCalifornia92805-
Pharmacology Research InstituteLos AlamitosCalifornia90720-
Wr Pri LlcNewport BeachCalifornia92660-
ATP Clinical ResearchOrangeCalifornia92866-
Sunwise Clinical ResearchWalnut CreekCalifornia94596-
Envision Trials LLCBonita SpringsFlorida34134-
Clinical Research of BrandonBrandonFlorida33511-
Healthcare Innovations Institute IncCoral SpringsFlorida33067-
Brain Matters ResearchDelray BeachFlorida33445-
Science Connections LLCDoralFlorida33178-
Homestead Associates in Research IncHomesteadFlorida33033-
K2 Medical ResearchMaitlandFlorida32751-
Allied Biomedical Research Institute (ABRI), IncMiamiFlorida33155-4630-
Ocean Blue Medical Research Center Inc.MiamiFlorida33144-
South Florida Research Phase I-IVMiamiFlorida33166-
Sunshine Medical SolutionMiamiFlorida33186-
Wellness Research CenterMiamiFlorida33135-
Combined Research OrlandoOrlandoFlorida32803-
Intercoastal Medical GroupSarasotaFlorida34239-
Psych Me Medical Research IncTampaFlorida33614-
University of South FloridaTampaFlorida33613-
Bio Behavioral HealthToms RiverNew Jersey08755-
New Hope Clinical ResearchCharlotteNorth Carolina28211-
Horizon Clinical Research GroupCypressTexas77065-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3900-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Anaheim, CA

By research site
Advanced Research Center, Inc· Anaheim, CAPharmacology Research Institute· Los Alamitos, CAWr Pri Llc· Newport Beach, CAATP Clinical Research· Orange, CASunwise Clinical Research· Walnut Creek, CAEnvision Trials LLC· Bonita Springs, FL

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