ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Purpose
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.
Condition
- Agitation in Dementia, Including Alzheimer's Disease
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical diagnosis of probable Alzheimer's disease - Clinically significant symptoms of agitation secondary to probable Alzheimer's disease - Able to attend outpatient clinic visits with primary caregiver
Exclusion Criteria
- Unable to comply with study procedures - Considered medically inappropriate for study participation
Study Design
- Phase
- Phase 3
- 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-007 |
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks. |
|
|
Placebo Comparator Placebo |
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks |
|
Recruiting Locations
More Details
- NCT ID
- NCT02817906
- Status
- Terminated
- Sponsor
- Intra-Cellular Therapies, Inc.