Safety Study of MT-4666 in Subjects With Alzheimer's Disease

A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Inclusion Criteria:

• Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
• MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
• Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
• Appropriate caregiver available
• Subject living at home or in facilities who do not require continuous (24-hour) nursing care.

Exclusion Criteria:

• Diagnosis of any other disease which may cause dementia
• Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
• History of or current diagnosis of any psychosis
• History of myocardial infarction or unstable angina within six months before screening
• History of cerebrovascular disorder within 18 months before screening
• complication of hepatic disorder or renal dysfunction