A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations;

• Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

‣ Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or

⁃ Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;

• Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;

• Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;

• CGI-S score ≥ 4 at Screening and Baseline;

• Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;

• Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

Locations
United States
California
Clinical Site
RECRUITING
Anaheim
Clinical Site
RECRUITING
Costa Mesa
Clinical Site
RECRUITING
Los Alamitos
Clinical Site
NOT_YET_RECRUITING
Newport Beach
Florida
Clinical Site
NOT_YET_RECRUITING
Coral Springs
Clinical Site
RECRUITING
Delray Beach
Clinical Site
NOT_YET_RECRUITING
Hialeah
Clinical Site
RECRUITING
Maitland
Clinical Site
NOT_YET_RECRUITING
Miami
Clinical Site
RECRUITING
Miami
Clinical Site
NOT_YET_RECRUITING
Miami
Clinical Site
RECRUITING
Miami
Clinical Site
RECRUITING
Miami Springs
Clinical Site
NOT_YET_RECRUITING
Orlando
Clinical Site
NOT_YET_RECRUITING
Sarasota
New Jersey
Clinical Site
RECRUITING
Toms River
Contact Information
Primary
ITI Clinical Trials
ITCIClinicalTrials@itci-inc.com
6464409333
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2027-10
Participants
Target number of participants: 370
Treatments
Experimental: ITI-1284
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Intra-Cellular Therapies, Inc.

This content was sourced from clinicaltrials.gov