Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423228
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2007-01-17
Brief Title:
Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimers Disease
Sponsor:
Debiopharm International SA
Organization:
Debiopharm International SA
Study Overview
Official Title:
A Randomised Double-blind Double-dummy Oral Donepezil Controlled Study on the Safety and Efficacy of Repeated Monthly Subcutaneous Injections of a Sustained-release Implant of ZT 1 in Patients With Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2015-01
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:
BRAINz
Brief Summary:
Alzheimers disease is characterised by memory loss and difficulties with thinking These problems may be due to a deficiency in a brain chemical called acetylcholine Acetylcholine helps transmit messages between nerve cells Acetylcholine is degraded by an enzyme called acetylcholinesterase ZT-1 is a new drug derived from a plant extract already used in China for memory disorders which blocks the action of the enzyme and restores adequate levels of acetylcholine
This study will test the safety and efficacy of ZT-1 in the treatment of patients with Alzheimers disease
BRAINz stands for Better Recollection for Alzheimers patients with the Implant of ZT-1
This study will test the safety and efficacy of ZT-1 in the treatment of patients with Alzheimers disease
BRAINz stands for Better Recollection for Alzheimers patients with the Implant of ZT-1
Detailed Description:
This is a multicenter randomised double-blind double-dummy oral donepezil controlled study on the safety and efficacy of repeated monthly sc injections of a sustained-release implant of ZT 1 in patients with moderate Alzheimers Disease
The study enrolls patients aged 50 years with moderate AD with a MMSE score at study screening 14 and 22 The study aims to recruit 128 patients
The study is divided into 3 periods
1 A screening period
2 A 6-month treatment period consisting of one month of titration with an oral medication and 5 months of treatment with an implant administered under the skin every 4 weeks Oral treatment will be maintained throughout the treatment phase
3 A 2 week follow-up period
Patients will be randomized in a 11 ratio to one of 2 groups the ZT-1 investigational product treatment group or the donepezil active comparator treatment group
The study comprises a total of 11 visits including screening and follow-up An additional visit for PKPD assessment is scheduled in about 10 of patients
The study enrolls patients aged 50 years with moderate AD with a MMSE score at study screening 14 and 22 The study aims to recruit 128 patients
The study is divided into 3 periods
1 A screening period
2 A 6-month treatment period consisting of one month of titration with an oral medication and 5 months of treatment with an implant administered under the skin every 4 weeks Oral treatment will be maintained throughout the treatment phase
3 A 2 week follow-up period
Patients will be randomized in a 11 ratio to one of 2 groups the ZT-1 investigational product treatment group or the donepezil active comparator treatment group
The study comprises a total of 11 visits including screening and follow-up An additional visit for PKPD assessment is scheduled in about 10 of patients
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 |
|---|---|---|---|
| EUDRACT no 2006-005161-18 | None | None | None |