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NCT02817906 · ClinicalTrials.gov registry record · Phase 3
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
A Phase 3 study, sponsored by Intra-Cellular Therapies.
- Terminated
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT02817906: Clinical Trial Phase 3 study, sponsored by Intra-Cellular Therapies.
NCT02817906 is a Phase 3 study that was terminated before completion, run by Intra-Cellular Therapies. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02817906, a Phase 3 study, was terminated before completion, sponsored by Intra-Cellular Therapies.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.
Primary Outcome
The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C
Interventions
- DRUG Placebo
- DRUG ITI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2016-08-29 |
| Est. Completion | 2019-01-30 |
| Phase | Phase 3 |
Why NCT02817906 stopped before completion
NCT02817906 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02817906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02817906 about?
NCT02817906 is a clinical study titled "ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease". This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.
What is the current status of trial NCT02817906?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2016-08-29. Estimated completion is 2019-01-30.
What interventions are being tested in trial NCT02817906?
The interventions under investigation include: Placebo (DRUG), ITI-007 (DRUG).
Who is sponsoring clinical trial NCT02817906?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02817906's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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