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The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease.
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Ages Eligible for Study:
50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available
Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
Diagnosis of any other disease which may cause dementia
MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
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