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
Sponsored by
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
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
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
No
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
No
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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