Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease
BRAINz
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
2 other identifiers
interventional
228
3 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2007
Typical duration for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJanuary 14, 2015
January 1, 2015
2.2 years
January 17, 2007
January 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the MMSE score from baseline to week 25
baseline to week 25
Secondary Outcomes (5)
Responder rate as defined by at least 2 points improvement in the MMSE score;
baseline to week 25
Change on the ADAS-Cog 11 items subscale;
baseline to week 25
Change in the NPI-Q;
baseline to week 25
Change on the IADL scale;
baseline to week 25
Patient's convenience questionnaire.
baseline to week 25
Study Arms (2)
ZT-1
EXPERIMENTALZT-1 (investigational product)
Donepezil
ACTIVE COMPARATORDonepezil
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Presence of moderately severe probable AD, diagnosed according to the DSM-IV and the NINCDS-ADRDA criteria;
- MMSE score ≥ 14 and ≤ 22;
- Male/female patient aged \> 50 years; female patients should be of no child-bearing potential or postmenopausal (at least one year after last menses);
- Body mass index (BMI) between 18 and 29 kg/m2 inclusive;
- Has a caregiver, is living at home or in an assisted living facility, is able to attend ambulatory study visits;
- Naïve to donepezil;
- Has discontinued another AChEI and/or memantine at least 3 months prior to study visit 2 (Day 1);
- Has a CT or MRI scan excluding another structural brain disease and supporting diagnosis of AD; CT or MRI scan must have been performed within 6 months prior to study visit 2 (Day 1, baseline);
- Fluent in English (mother tongue or working language);
- Able to communicate well with the Investigator;
- Physically able to carry out functional tasks;
- Has given written informed consent together with the caregiver.
You may not qualify if:
- Presence of any disabling, severe or life-threatening disease (cardiac, respiratory, gastro-intestinal, neurological, epileptic, psychiatric, infectious, bone, endocrinologic);
- Inability to discontinue at least 2 weeks prior to visit 2 (Day 1) (or within 5 drug half-lives, whichever is longer) any medication listed as prohibited;
- Proven or clinically suspected other type of dementia such as vascular dementia, post-traumatic dementia, fronto-temporal dementia, dementia associated with Parkinson's Disease, infectious disease HIV, syphilis), folate or vitamin B12 deficiency, hypothyroidism etc.;
- Significant liver impairment with ASAT, ALAT \>=3x the upper normal limit at screening;
- Significant kidney impairment with serum creatinine \>=2x the upper normal limit at screening;
- Presence of cardiac rhythm disorder, in particular bradycardia (\< 60 bpm), conduction abnormalities such as AV block; presence of active ischaemia (such as unstable angina pectoris) or recent myocardial infarction, QT interval ≥ 450 msec at screening, QRS complex ≥ 110 msec at screening (ECG must be within normal limits at screening);
- Uncontrolled arterial hypertension i.e. patients with systolic blood pressure (BP) \>=160 mmHg and/or diastolic \>=100 mmHg, at screening despite regular medication;
- Uncontrolled arterial hypotension, i.e. patients with systolic BP ≤ 100 mmHg and/or presenting a fall of systolic BP ≥ 20 mmHg or a fall of diastolic BP \>=10 mmHg after the 2 min Schellong test at screening;
- Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or his/her participation to the study;
- Participation in another study with an experimental drug within 3 months before study visit 2 (Day 1, baseline) or within 5 drug half-lives of the investigational drug (whichever is the longer);
- Known peripheral cholinergic intolerance, i.e. with previously prescribed AChEI(s);
- Known hypersensitivity to any of the test materials or related compounds, including lactose, present in the donepezil and placebo capsules;
- Known active use of recreational drug or alcohol dependence, current alcohol abuse;
- Inability to comply fully with the protocol;
- Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Central Coast Neuroscience Research
East Gosford, New South Wales, 2250, Australia
Hornsby-Kuring-gai Health Service
Hornsby, New South Wales, 2077, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
St George's Hospital
Kew, Victoria, 3101, Australia
Austin Health Repatriation Hospital
West Heidelberg, Victoria, 3081, Australia
Hollywood Specialist Centre
Nedlands (Perth), Western Australia, 6009, Australia
Calgary West Medical Centre
Calgary, Alberta, T3C 3P1, Canada
Castledowns Medicentre
Edmonton, Alberta, Canada
Saibal Nandy Professional Corporation
Medicine Hat, Alberta, T1A 4C2, Canada
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2W7, Canada
Gerontion Research Inc.
Toronto, Ontario, M6M 3Z5, Canada
Neuro Rive-Sud
Montreal, Quebec, J4V 2J2, Canada
Jewish General Hospital
Montreal, Quebec, P.Q. H3T 1E2, Canada
The Medical Arts Health Research Group
Kelowna, V1Y 3G8, Canada
Douglas Hospital Research Center
Montreal, H4H 1R3, Canada
The Medical Arts Health Research Group
Penticton, V2A 5C8, Canada
OPMHS
Crowborough, East Sussex, TN61HB, United Kingdom
Camden and Islington Mental Health Trust
London, London, NW1 9DB, United Kingdom
Glasgow Memory Clinic
Glasgow, Scotland, G20 0XA, United Kingdom
Llandough Hospital
Penarth, Wales, CF64 2XX, United Kingdom
Royal Blackburn Hospital
Blackburn, M8 5RB, United Kingdom
North Manchester General Hospital
Manchester, M85RB, United Kingdom
New Castle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
MARC - Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Related Publications (1)
Wilkinson D, Roughan L. The BRAINz trial: a novel approach to acetylcholinesterase-inhibitor treatment for Alzheimer's disease. Future Neurol 2(4):379-382,2007.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emmanuel Tamches, MD
Debiopharm SA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
February 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
January 14, 2015
Record last verified: 2015-01