Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-05 @ 1:06 AM
Study NCT ID:
NCT06651567
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Sponsor:
Intra-Cellular Therapies, Inc.
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study will be conducted in 3 periods:
* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
* Double-blind Treatment Period (12 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo;
* Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.
* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
* Double-blind Treatment Period (12 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo;
* Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: