NCT01764243
Completed
Phase 2
A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
Overview
- Phase
- Phase 2
- Intervention
- MT-4666
- Conditions
- Alzheimer's Disease
- Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Enrollment
- 450
- Primary Endpoint
- Change from baseline in ADAS-cog-13
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
MT-4666 Low Dose
low dose
Intervention: MT-4666
MT-4666 High Dose
high dose
Intervention: MT-4666
Placebo
placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in ADAS-cog-13
Time Frame: Baseline and Week 24
Secondary Outcomes
- 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)
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