A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

PHASE2RecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

October 22, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

November 30, 2027

Conditions
Agitation Associated With Alzheimer's Dementia
Interventions
DRUG

ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

DRUG

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Trial Locations (17)

27607

NOT_YET_RECRUITING

Clinical Site, Raleigh

32751

NOT_YET_RECRUITING

Clinical Site, Maitland

32803

NOT_YET_RECRUITING

Clinical Site, Orlando

33032

NOT_YET_RECRUITING

Clinical Site, Miami

33135

NOT_YET_RECRUITING

Clinical Site, Miami

33137

NOT_YET_RECRUITING

Clinical Site, Miami

33155

RECRUITING

Clinical Site, Miami

33178

NOT_YET_RECRUITING

Clinical Site, Doral

33186

RECRUITING

Clinical Site, Miami

33445

NOT_YET_RECRUITING

Clinical Site, Delray Beach

33487

NOT_YET_RECRUITING

Clinical Site, Boca Raton

34134

NOT_YET_RECRUITING

Clinical Site, Bonita Springs

78681

NOT_YET_RECRUITING

Clinical Site, Round Rock

92626

RECRUITING

Clinical Site, Costa Mesa

92660

NOT_YET_RECRUITING

Clinical Site, Newport Beach

92805

NOT_YET_RECRUITING

Clinical Site, Anaheim

08755

NOT_YET_RECRUITING

Clinical Site, Toms River

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY