A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Purpose
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
Condition
- Agitation Associated With Alzheimer's Dementia
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Alzheimer'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 Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or - Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan; - Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition - Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline; - CGI-S score ≥ 4 at Screening and Baseline; - Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;
Exclusion Criteria
- Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment; - Has been diagnosed with one or more of the following psychiatric conditions: - Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia; - Bipolar disorder; - Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening; - Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening; - The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ITI-1284 |
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration |
|
|
Placebo Comparator Placebo |
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration |
|
Recruiting Locations
Advanced Research Center, Inc
Anaheim, California 92805
Anaheim, California 92805
ATP Clinical Research
Costa Mesa, California 92626
Costa Mesa, California 92626
SFM Clinical Research
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Envision Trials LLC
Bonita Springs, Florida 34134
Bonita Springs, Florida 34134
Clinical Research of Brandon
Brandon, Florida 33511
Brandon, Florida 33511
Science Connections LLC
Doral, Florida 33178
Doral, Florida 33178
Direct Helpers Medical Center, Inc.
Hialeah, Florida 33012-3618
Hialeah, Florida 33012-3618
Homestead Associates in Research Inc
Homestead, Florida 33033
Homestead, Florida 33033
K2 Medical Research
Maitland, Florida 32751
Maitland, Florida 32751
Neurology Associates PA
Maitland, Florida 32751
Maitland, Florida 32751
Vital Care Research
Miami, Florida 33122
Miami, Florida 33122
Advanced Clinical Research Network
Miami, Florida 33135
Miami, Florida 33135
Wellness Research Center
Miami, Florida 33135
Miami, Florida 33135
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida 33155-4630
Miami, Florida 33155-4630
South Florida Research Phase I-IV
Miami, Florida 33166
Miami, Florida 33166
Miami Jewish Health System
Miami, Florida 33180
Miami, Florida 33180
Sunshine Medical Research Studies Inc
Miami, Florida 33186
Miami, Florida 33186
Charter Research
Orlando, Florida 32803
Orlando, Florida 32803
Psych Me Medical Research Inc
Tampa, Florida 33614
Tampa, Florida 33614
Quantum Research Associates Corp
Tampa, Florida 33614
Tampa, Florida 33614
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Tufts University School of Medicine
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Oasis Clinical Research LLC
Las Vegas, Nevada 89121
Las Vegas, Nevada 89121
Bio Behavioral Health
Toms River, New Jersey 08755
Toms River, New Jersey 08755
More Details
- Status
- Recruiting
- Sponsor
- Intra-Cellular Therapies, Inc.
Detailed Description
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) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.