Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02442778
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2015-05-11
Brief Title:
Efficacy Safety and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimers Type
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of AVP-786 Deuterated d6-Dextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Agitation in Patients With Dementia of the Alzheimers Type
Status:
COMPLETED
Status Verified Date:
2022-08
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:
Participants with agitation secondary to dementia of the Alzheimers type The diagnosis of probable Alzheimers disease AD will be based on the 2011 Diagnostic Guidelines for Alzheimers Disease issued by the National Institute on Aging NIA-Alzheimers Association AA workgroups
Detailed Description:
Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD
This is a multicenter randomized placebo-controlled study consisting of 12 weeks of treatment
Approximately 470 participants will be enrolled at approximately 75 centers in North America
Study medication will be administered orally twice-daily from Day 1 through Week 12 Day 85 Screening will occur within approximately 4 weeks prior to randomization Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
This is a multicenter randomized placebo-controlled study consisting of 12 weeks of treatment
Approximately 470 participants will be enrolled at approximately 75 centers in North America
Study medication will be administered orally twice-daily from Day 1 through Week 12 Day 85 Screening will occur within approximately 4 weeks prior to randomization Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
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