Safety and Efficacy of MT-4666
- Registration Number
- NCT01764243
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo MT-4666 Low Dose MT-4666 low dose MT-4666 High Dose MT-4666 high dose
- Primary Outcome Measures
Name Time Method Change from baseline in ADAS-cog-13 Baseline and Week 24
- Secondary Outcome Measures
Name Time Method Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Baseline and Week 24 Change from baseline in Modified Crichton Scale Baseline and Week 24 Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Baseline and Week 24 Change from baseline in Mini-Mental State Examination (MMSE) Baseline and Week 24 Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) Baseline and Week 24 Change from baseline in Neuropsychiatric Inventory (NPI) Baseline and Week 24