Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
450 participants
INTERVENTIONAL
2012-11-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-4666 Low Dose
low dose
MT-4666
low dose, high dose
MT-4666 High Dose
high dose
MT-4666
low dose, high dose
Placebo
placebo
Placebo
Interventions
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MT-4666
low dose, high dose
Placebo
Eligibility Criteria
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Inclusion 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yu Nakamura, M.D., Ph.D.
Role: STUDY_DIRECTOR
Kagawa University School of Medicine
Akira Homma, M.D.
Role: STUDY_DIRECTOR
Tokyo Dementia Care Research and Training Center
Shun Shimohama, M.D., D. Med. SC
Role: STUDY_DIRECTOR
Sapporo Medical University
Locations
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Kanto, , Japan
Countries
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Other Identifiers
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P211-03
Identifier Type: -
Identifier Source: org_study_id
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