Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423085
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2007-01-11
Brief Title:
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 24-week Multicenter Randomized Double-blind Placebo-controlled Parallel-group Dose-finding Evaluation of the Efficacy Safety and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimers Disease MMSE 10-20
Status:
COMPLETED
Status Verified Date:
2014-01
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 was to investigate the 5cm2 and 10cm2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimers Disease MMSE Mini Mental State Examination 10-20 A 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimers Disease AD
Detailed Description:
Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms placebo rivastigmine 5 cm2 and rivastigmine 10 cm2 in a ratio of 111 During the Double-blind treatment phase patients entered a 16-week Titration Period followed by an 8-week Maintenance Period During the open-label extension phase all patients started treatment with a 25 cm2 patch and the dose was increased to 10 cm2 over a 16-week titration period followed by a maintenance period of 36 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CENA713D1301E1 | None | None | None |