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

Exclusion Criteria

• •1. Presence of any disabling, severe or life-threatening disease (cardiac, respiratory, gastro-intestinal, neurological, epileptic, psychiatric, infectious, bone, endocrinologic);
• •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.