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

Alzheimer's Disease Clinical Trial

Official title:

A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02327182
• Other study ID #: P211-05
• Status: Terminated
• Phase: Phase 3
• First received: December 23, 2014
• Last updated: November 12, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MT-4666

Locations

Country	Name	City	State
Japan	Investigational site	Osaka	Kansai

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in Mini Mental State Examination (MMSE)		baseline to Week 52	No
Secondary	Change in Neuropsychiatric Inventory (NPI) total score		baseline to Week 52	No