Safety Study of MT-4666 in Subjects With Alzheimer's Disease

Phase 3

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: MT-4666

• Registration Number: NCT02327182
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-30
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
• MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
• Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
• Appropriate caregiver available
• Subject living at home or in facilities who do not require continuous (24-hour) nursing care.

Exclusion Criteria

• Diagnosis of any other disease which may cause dementia
• 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
• complication of hepatic disorder or renal dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-4666 low dose	MT-4666	Low Dose, Tablet, Once Daily, For 52 Weeks
MT-4666 high dose	MT-4666	High Dose, Tablet, Once Daily, For 52 Weeks

Primary Outcome Measures

Name	Time	Method
Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS)	Up to week 56

Secondary Outcome Measures

Name	Time	Method
Change in Neuropsychiatric Inventory (NPI) total score	baseline to Week 52
Change in Mini Mental State Examination (MMSE)	baseline to Week 52

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Osaka, Kansai, Japan