Clinical trial NCT02817906: ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Agitation in Dementia, Including Alzheimer's Disease
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 177
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 dementia, including Alzheimer's disease.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
timeFrame: 4 weeks (28 Days)
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
timeFrame: 4 weeks (28 Days)
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Rogers
country: United States
state: Arkansas
city: Costa Mesa
country: United States
state: California
city: Glendale
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lemon Grove
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Riverside
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Suwanee
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Marlton
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Centerville
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Susan Kozauer, M.D.
role: STUDY_DIRECTOR
References: