Status:
TERMINATED
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Agitation in Dementia, Including Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- Unable to comply with study procedures
- Considered medically inappropriate for study participation
Key Trial Info
Start Date :
August 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT02817906
Start Date
August 29 2016
End Date
January 30 2019
Last Update
June 29 2021
Active Locations (26)
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1
Sun City, Arizona, United States
2
Little Rock, Arkansas, United States
3
Rogers, Arkansas, United States
4
Costa Mesa, California, United States