Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02079246
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2014-02-28
Brief Title:
Long-term Safety and Tolerability of Idalopirdine Lu AE58054 as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimers Disease
Sponsor:
H Lundbeck AS
Organization:
H Lundbeck AS
Study Overview
Official Title:
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine Lu AE58054 as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2018-08
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:
STAR Extension
Brief Summary:
To evaluate the long-term safety and tolerability of idalopirdine Lu AE58054 as adjunctive therapy to donepezil in patients with mild-moderate Alzheimers Disease AD
Detailed Description:
This is an interventional multi-national multi-site open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A NCT01955161 or 14862A NCT02006641
Patients received 28-weeks of open-label treatment with idalopirdine 60 mgday option to reduce to 30 mgday as adjunctive treatment to donepezil Approximately 100 patients who had completed the initial 28-week period OLEX were included in a 24 week open-label treatment period with memantine OLEX-MEM that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated
Patients received 28-weeks of open-label treatment with idalopirdine 60 mgday option to reduce to 30 mgday as adjunctive treatment to donepezil Approximately 100 patients who had completed the initial 28-week period OLEX were included in a 24 week open-label treatment period with memantine OLEX-MEM that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated
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 |
|---|---|---|---|
| 2013-000001-23 | EUDRACT_NUMBER | None | None |