NCT00423228

Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 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 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.

Conditions

• Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ZT-1	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.
DRUG	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-01-18
• Last updated: 2015-01-14

Locations

28 sites across 3 countries: Australia, Canada, United Kingdom