Title
Safety and Efficacy of MT-4666
A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
Phase
Phase 2Lead Sponsor
Mitsubishi TanabeStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Alzheimer's DiseaseIntervention/Treatment
encenicline ...Study Participants
450The 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.
low dose, high dose
Inclusion Criteria: 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 Exclusion Criteria: 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
