Safety and Efficacy of MT-4666
NCT01764243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2015-09-28
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.
Conditions
Interventions
- DRUG
-
MT-4666
low dose, high dose
- DRUG
Sponsors & Collaborators
-
Mitsubishi Tanabe Pharma Corporation
lead INDUSTRY
Principal Investigators
-
Yu Nakamura, M.D., Ph.D. · Kagawa University School of Medicine
-
Akira Homma, M.D. · Tokyo Dementia Care Research and Training Center
-
Shun Shimohama, M.D., D. Med. SC · Sapporo Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-07-31
Countries
- Japan
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