search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MT-4666
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring MT-4666, α7 nicotinic acetylcholine receptor agonist, Alzheimer's Disease, Cognitive function, Dementia, Central Nervous System Agents

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MT-4666 low dose

MT-4666 high dose

Arm Description

Low Dose, Tablet, Once Daily, For 52 Weeks

High Dose, Tablet, Once Daily, For 52 Weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in Mini Mental State Examination (MMSE)
Change in Neuropsychiatric Inventory (NPI) total score

Full Information

First Posted
December 23, 2014
Last Updated
November 12, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02327182
Brief Title
Safety Study of MT-4666 in Subjects With Alzheimer's Disease
Official Title
A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to the benefit-risk balance of MT-4666.
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
MT-4666, α7 nicotinic acetylcholine receptor agonist, Alzheimer's Disease, Cognitive function, Dementia, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-4666 low dose
Arm Type
Experimental
Arm Description
Low Dose, Tablet, Once Daily, For 52 Weeks
Arm Title
MT-4666 high dose
Arm Type
Experimental
Arm Description
High Dose, Tablet, Once Daily, For 52 Weeks
Intervention Type
Drug
Intervention Name(s)
MT-4666
Primary Outcome Measure Information:
Title
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)
Time Frame
Up to week 56
Secondary Outcome Measure Information:
Title
Change in Mini Mental State Examination (MMSE)
Time Frame
baseline to Week 52
Title
Change in Neuropsychiatric Inventory (NPI) total score
Time Frame
baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Nakamura, M.D., Ph.D.
Organizational Affiliation
Kagawa University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, M.D.
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Osaka
State/Province
Kansai
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs