TerminatedPhase 3

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

Stopped: Pre-specified Interim Analysis Indicated Futility

United States177 participantsStarted 2016-08-29

Plain-language 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.

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

Timeframe: 4 weeks (28 Days)

Trial details

NCT IDNCT02817906

SponsorIntra-Cellular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

Results submitted2021-05-13

View on ClinicalTrials.gov More Agitation in Dementia, Including Alzheimer's Disease trials