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

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MT-4666 low dose

Low Dose, Tablet, Once Daily, For 52 Weeks

Group Type EXPERIMENTAL

MT-4666

Intervention Type DRUG

MT-4666 high dose

High Dose, Tablet, Once Daily, For 52 Weeks

Group Type EXPERIMENTAL

MT-4666

Intervention Type DRUG

Interventions

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MT-4666

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No