Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor

Inclusion Criteria

• •1. Written informed consent as dictated by local legal circumstances.
• •2. Age range: adult patients between 50-85 years of age.
• •3. Gender: men and women. Women of child bearing potential or within two years of the menopause must have a negative urine pregnancy test at the Screening Visit.
• •4. A documented history of confirmed Alzheimer's disease
• •5. Dementia severity: MMSE score \> 15,
• •6. Stable AChE inhibitor dose for 2 months prior to Screening visit.
• •7. Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit.
• •8. Stable doses of B12 and/or Folic acid supplements for at least 3 months prior to enrollment and throughout the study.
• •9. Cranial image: no evidence of focal disease to account for dementia (established by CT, PET or MRI). If there is no such available scan (CT, PET or MRI), one must be performed prior to enrollment.
• •10. Health: Physically acceptable for the study with no pathology likely to occur during or immediately after the study, as confirmed by medical history and exam and ECG.
• •11. Clinical laboratory values must be within normal limits, or judged not clinically significant by the investigator.
• •12. Residence: Stable home situation with no planned move during the 28-week investigational period.
• •13. A family member or a regular caregiver that will be available for visits and will ensure compliance. The caregiver must speak fluent Hebrew, Russian or English.
• •14. Ability to ingest oral medication and participate in all scheduled evaluations.
• •15. Ability to spend 2 daily hours outdoors exposed to sunlight.