Moderate Alzheimer's Disease Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03959553 -
GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)
|
Phase 2 |