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

Conditions

• Agitation Associated With Alzheimer's Dementia

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia

Key Dates

Start date

Oct 22, 2024

Status verified

Jan 2026

Primary completion

Oct 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ITI-1284
  ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
• Placebo Comparator: Placebo
  Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Primary Outcome Measure

Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: Week 12 ]

Central Contacts

• ITI Clinical Trials
  646-440-9333
  [email protected]

Locations (30)

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