Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease (BRAINz)
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|ClinicalTrials.gov Identifier: NCT00423228|
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : January 14, 2015
Alzheimer's 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 Alzheimer's disease.
BRAINz stands for Better Recollection for Alzheimer's patients with the Implant of ZT-1.
|Condition or disease||Intervention/treatment||Phase|
|Moderate Alzheimer's Disease||Drug: ZT-1 Drug: Donepezil||Not Applicable|
This is a multicenter, randomised, double-blind, double-dummy, oral donepezil controlled study on the safety and efficacy of repeated monthly s.c. injections of a sustained-release implant of ZT 1 in patients with moderate Alzheimer's 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:
- A screening period
- 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
- A 2 week follow-up period.
Patients will be randomized in a 1:1 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 PK/PD assessment is scheduled in about 10% of patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||228 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Alzheimer's Disease|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
ZT-1 (investigational product)
Patients in the ZT-1 treatment group will receive ZT 1-1 mg capsules administered p.o. daily during the first month of treatment, followed by ZT-1 implants (9 mg) administered s.c. during the second month of treatment, followed by ZT-1 implants (12 mg) administered s.c. every 4 weeks during months 3 to 6 of treatment. Patients in the ZT-1 treatment group will receive dummy donepezil capsules during months 2 to 6 of the treatment period.
Active Comparator: Donepezil
Patients in the donepezil treatment group will receive donepezil 5 mg capsules administered p.o. during the first month of treatment, followed by donepezil 10 mg/day during months 2 to 6 of the treatment period. Patients in the donepezil treatment group will also receive s.c. injections of dummy ZT 1 implants every 4 weeks during months 2 to 6 of the treatment period.
Other Name: Aricept
- Change in the MMSE score from baseline to week 25 [ Time Frame: baseline to week 25 ]
- Responder rate as defined by at least 2 points improvement in the MMSE score; [ Time Frame: baseline to week 25 ]
- Change on the ADAS-Cog 11 items subscale; [ Time Frame: baseline to week 25 ]
- Change in the NPI-Q; [ Time Frame: baseline to week 25 ]
- Change on the IADL scale; [ Time Frame: baseline to week 25 ]
- Patient's convenience questionnaire. [ Time Frame: baseline to week 25 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423228
|Study Director:||Emmanuel Tamches, MD||Debiopharm SA|