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Safety and Efficacy of MT-4666

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

MT-4666

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available

Exclusion Criteria:

Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
Diagnosis of any other disease which may cause dementia
MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-4666 Low Dose

MT-4666 High Dose

Placebo

Arm Description

low dose

high dose

placebo

Outcomes

Primary Outcome Measures

Change from baseline in ADAS-cog-13

Secondary Outcome Measures

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)

Change from baseline in Mini-Mental State Examination (MMSE)

Change from baseline in Neuropsychiatric Inventory (NPI)

Change from baseline in Modified Crichton Scale

Full Information

NCT ID

NCT01764243

First Posted

December 26, 2012

Last Updated

September 24, 2015

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01764243

Brief Title

Safety and Efficacy of MT-4666

Official Title

A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MT-4666 Low Dose

Arm Type

Experimental

Arm Description

low dose

Arm Title

MT-4666 High Dose

Arm Type

Experimental

Arm Description

high dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

MT-4666

Intervention Description

low dose, high dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in ADAS-cog-13

Time Frame

Baseline and Week 24

Secondary Outcome Measure Information:

Title

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Time Frame

Baseline and Week 24

Title

Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time Frame

Baseline and Week 24

Title

Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)

Time Frame

Baseline and Week 24

Title

Change from baseline in Mini-Mental State Examination (MMSE)

Time Frame

Baseline and Week 24

Title

Change from baseline in Neuropsychiatric Inventory (NPI)

Time Frame

Baseline and Week 24

Title

Change from baseline in Modified Crichton Scale

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available Exclusion Criteria: Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1 Diagnosis of any other disease which may cause dementia MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD 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

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

Akira Homma, M.D.

Organizational Affiliation

Tokyo Dementia Care Research and Training Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shun Shimohama, M.D., D. Med. SC

Organizational Affiliation

Sapporo Medical University

Official's Role

Study Director

Facility Information:

City

Kanto

Country

Japan

12. IPD Sharing Statement

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Safety and Efficacy of MT-4666

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