Status:
COMPLETED
Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease
Lead Sponsor:
Debiopharm International SA
Conditions:
Moderate Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
NA
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 mes...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00423228
Start Date
February 1 2007
End Date
April 1 2009
Last Update
January 14 2015
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Coast Neuroscience Research
East Gosford, New South Wales, Australia, 2250
2
Hornsby-Kuring-gai Health Service
Hornsby, New South Wales, Australia, 2077
3
Southern Neurology
Kogarah, New South Wales, Australia, 2217
4
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032