Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159673
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-27
Brief Title:
ACP-204 in Adults With Alzheimers Disease Psychosis
Sponsor:
ACADIA Pharmaceuticals Inc
Organization:
ACADIA Pharmaceuticals Inc
Study Overview
Official Title:
A Master Protocol for Three Independent Seamlessly Enrolling Double-blind Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimers Disease Psychosis
Status:
RECRUITING
Status Verified Date:
2023-11
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 master protocol for 3 independent seamlessly enrolling multicenter randomized double-blind placebo-controlled parallel-group studies in patients with ADP
Substudy 1 Phase 2 will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo This substudy will be initiated first
Substudies 2A and 2B both Phase 3 will be confirmatory studies of either both doses ACP-204 30 and 60 mg respectively or a single dose from Part 1 vs placebo Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1
All 3 substudies will be analyzed independently of each other
Each substudy individually will consist of a screening period up to 42 days a double-blind treatment period 6 weeks a safety follow-up period 30 days for patients not rolling over into an open-label extension study and vital status follow-up for patients who terminated their substudy early
Substudy 1 Phase 2 will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo This substudy will be initiated first
Substudies 2A and 2B both Phase 3 will be confirmatory studies of either both doses ACP-204 30 and 60 mg respectively or a single dose from Part 1 vs placebo Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1
All 3 substudies will be analyzed independently of each other
Each substudy individually will consist of a screening period up to 42 days a double-blind treatment period 6 weeks a safety follow-up period 30 days for patients not rolling over into an open-label extension study and vital status follow-up for patients who terminated their substudy early
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None