ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Agitation in Dementia, Including Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02817906

Run by

Intra-Cellular Therapies, Inc.

People needed

177

Starts

2016-08-29

Expected to finish

2019-01-30

Last updated by the study team

2021-06-29

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unable to comply with study procedures
• Considered medically inappropriate for study participation

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Rogers, Arkansas, United States
• Study site — Costa Mesa, California, United States
• Study site — Glendale, California, United States
• Study site — Irvine, California, United States
• Study site — Lemon Grove, California, United States
• Study site — Long Beach, California, United States
• Study site — Oceanside, California, United States
• Study site — Riverside, California, United States
• Study site — Santa Ana, California, United States
• Study site — Hallandale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Suwanee, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Berlin, New Jersey, United States
• Study site — Marlton, New Jersey, United States
• Study site — Toms River, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Centerville, Ohio, United States
• Study site — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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