Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651567
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimers Dementia
Sponsor:
None
Organization:
None
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 Alzheimers Dementia
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 placebo-controlled flexible-dose study of the efficacy safety and tolerability of ITI-1284 in patients with agitation associated with Alzheimers 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 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 12 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