Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease
NCT ID: NCT00423228
Last Updated: 2015-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
228 participants
INTERVENTIONAL
2007-02-28
2009-04-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZT-1
ZT-1 (investigational product)
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.
Donepezil
Donepezil
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MMSE score ≥ 14 and ≤ 22;
3. Male/female patient aged \> 50 years; female patients should be of no child-bearing potential or postmenopausal (at least one year after last menses);
4. Body mass index (BMI) between 18 and 29 kg/m2 inclusive;
5. Has a caregiver, is living at home or in an assisted living facility, is able to attend ambulatory study visits;
6. Naïve to donepezil;
7. Has discontinued another AChEI and/or memantine at least 3 months prior to study visit 2 (Day 1);
8. 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);
9. Fluent in English (mother tongue or working language);
10. Able to communicate well with the Investigator;
11. Physically able to carry out functional tasks;
12. Has given written informed consent together with the caregiver.
Exclusion Criteria
2. 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;
3. 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.;
4. Significant liver impairment with ASAT, ALAT \>=3x the upper normal limit at screening;
5. Significant kidney impairment with serum creatinine \>=2x the upper normal limit at screening;
6. 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);
7. Uncontrolled arterial hypertension i.e. patients with systolic blood pressure (BP) \>=160 mmHg and/or diastolic \>=100 mmHg, at screening despite regular medication;
8. 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;
9. Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or his/her participation to the study;
10. 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);
11. Known peripheral cholinergic intolerance, i.e. with previously prescribed AChEI(s);
12. Known hypersensitivity to any of the test materials or related compounds, including lactose, present in the donepezil and placebo capsules;
13. Known active use of recreational drug or alcohol dependence, current alcohol abuse;
14. Inability to comply fully with the protocol;
15. Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason.
50 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Emmanuel Tamches, MD
Role: STUDY_DIRECTOR
Debiopharm SA
Locations
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Central Coast Neuroscience Research
East Gosford, New South Wales, Australia
Hornsby-Kuring-gai Health Service
Hornsby, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
St George's Hospital
Kew, Victoria, Australia
Austin Health Repatriation Hospital
West Heidelberg, Victoria, Australia
Hollywood Specialist Centre
Nedlands (Perth), Western Australia, Australia
Calgary West Medical Centre
Calgary, Alberta, Canada
Castledowns Medicentre
Edmonton, Alberta, Canada
Saibal Nandy Professional Corporation
Medicine Hat, Alberta, Canada
Parkwood Hospital
London, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Gerontion Research Inc.
Toronto, Ontario, Canada
Neuro Rive-Sud
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
The Medical Arts Health Research Group
Kelowna, , Canada
Douglas Hospital Research Center
Montreal, , Canada
The Medical Arts Health Research Group
Penticton, , Canada
OPMHS
Crowborough, East Sussex, United Kingdom
Camden and Islington Mental Health Trust
London, London, United Kingdom
Glasgow Memory Clinic
Glasgow, Scotland, United Kingdom
Llandough Hospital
Penarth, Wales, United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
New Castle General Hospital
Newcastle upon Tyne, , United Kingdom
MARC - Moorgreen Hospital
Southampton, , United Kingdom
Countries
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References
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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.
Related Links
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Sponsor of the Study
Alzheimer's Disease Education and Referral (ADEAR) Center
Other Identifiers
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EUDRACT no. 2006-005161-18
Identifier Type: -
Identifier Source: secondary_id
DEB-ZTSR-201
Identifier Type: -
Identifier Source: org_study_id