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

Mitsubishi Tanabe Pharma

Status and phase

Terminated

Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: MT-4666

Study type

Interventional

Funder types

Industry

Identifiers

NCT02327182

P211-05

Details and patient eligibility

About

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).

Enrollment

117 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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