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ITI-1284 for Psychosis in Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a high likelihood for amyloid pathology consistent with AD, confirmed by blood-based biomarker at Screening or documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
Be older than 18 years old
Must not have
Diagnosed with schizophrenia, schizoaffective disorder, or other psychotic disorder not related to Alzheimer's dementia, or bipolar disorder
Unable or unwilling to discontinue drugs with known psychotropic properties or significant central nervous system effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6

Summary

This trial is testing a new medication called ITI-1284 to see if it is effective, safe, and well-tolerated in treating psychosis in patients with Alzheimer's disease.

Who is the study for?
This trial is for people with Alzheimer's who are experiencing psychosis. Participants should be diagnosed with Alzheimer's Disease and currently have symptoms of psychosis. The study excludes individuals who don't meet the specific diagnostic criteria, those on certain medications, or anyone whose condition might interfere with the study.
What is being tested?
The trial is testing ITI-1284 to see if it helps treat psychosis in Alzheimer's patients compared to a placebo (a substance with no active drug). It’s a controlled test where patients are randomly chosen to receive either ITI-1284 or placebo without knowing which one they're getting.
What are the potential side effects?
Possible side effects of ITI-1284 could include dizziness, sleepiness, upset stomach, changes in appetite or weight, dry mouth, blurred vision, constipation and potential heart-related issues. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tests show signs of Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia, schizoaffective disorder, or another psychotic disorder not related to Alzheimer's, or bipolar disorder.
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I cannot or will not stop taking medications that affect my mood or brain function.
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I am in the hospital or need skilled nursing care for a condition that is not dementia.
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I am not bedridden and do not have a severe unstable health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BEHAVE-AD psychosis subscale score
Secondary study objectives
CGI-S score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ITI-1284Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
37 Previous Clinical Trials
9,382 Total Patients Enrolled
~247 spots leftby Sep 2027
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