Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540833
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Flexible-dose Study to Assess the Efficacy Safety and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind parallel-group placebo-controlled flexible-dose study evaluating the efficacy safety and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD
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 6 weeks during which all patients will be randomized in a 11 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 6 weeks during which all patients will be randomized in a 11 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None