Trials / Terminated
TerminatedNCT02817906
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Intra-Cellular Therapies, Inc. · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITI-007 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-08-29
- Primary completion
- 2019-01-30
- Completion
- 2019-01-30
- First posted
- 2016-06-29
- Last updated
- 2021-06-29
- Results posted
- 2021-06-29
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02817906. Inclusion in this directory is not an endorsement.