Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01399125
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2011-07-19
Brief Title:
A 24-Week Efficacy Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimers Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 24-Week Randomized Double-blind Double-dummy Parallel-group Active-controlled Study to Assess the Efficacy Safety and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimers Disease Mini-Mental State Examination MMSE 10-20
Status:
COMPLETED
Status Verified Date:
2014-07
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:
The purpose of this study is to assess the efficacy safety and tolerability of Exelon patch in patients with probable AD MMSE 10-20 in order to support a planned regulatory submission and registration of Exelon transdermal patch in China The study is designed to confirm the non-inferiority of the efficacy of Exelon patch target 10 cm² patch size versus Exelon capsules target 60 mg bid dose on cognition using the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog
Detailed Description:
None
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