ITI-1284 for Psychosis Associated With Alzheimer's Disease
This study is testing ITI-1284, a rapidly dissolving tablet taken once daily, to see if it can help reduce psychosis (a mental health condition where you lose touch with reality) in people with Alzheimer's disease. Researchers want to understand if ITI-1284 is effective and safe compared to a placebo (an inactive substance). You may be able to join if you are 55 or older, have psychosis linked to Alzheimer's, and can understand the study or have someone legally authorized to consent for you. The main way success will be measured is by looking at changes in psychosis symptoms after 6 weeks. The current status of this study is unclear, but it plans to enroll about 370 participants.
- Study design
- This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either ITI-1284 or a placebo, and neither you nor your doctor will know which you are receiving. The study aims to enroll about 370 participants.
- What's involved
- You would go through a screening period of up to 4 weeks to see if you qualify. If eligible, you would take the study drug once daily for 6 weeks. There will also be a safety follow-up visit about 30 days after your last dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have a safety follow-up visit approximately 30 days after their last dose of the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
At a glance
Conditions
Where it's being run
67 sites across 16 statesStudy leadership
- Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.
Who to contact
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What this trial measures
- BEHAVE-AD psychosis subscale scoreWeek 6
The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36.