Safety and Efficacy of MT-4666

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01764243
First received: December 26, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: MT-4666
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change from baseline in ADAS-cog-13 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Modified Crichton Scale [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-4666 Low Dose
low dose
Drug: MT-4666
low dose, high dose
Experimental: MT-4666 High Dose
high dose
Drug: MT-4666
low dose, high dose
Placebo Comparator: Placebo
placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764243

Contacts
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Recruiting
Kanto, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Yu Nakamura, M.D., Ph.D. Kagawa University School of Medicine
Study Director: Akira Homma, M.D. Tokyo Dementia Care Research and Training Center
Study Director: Shun Shimohama, M.D., D. Med. SC Sapporo Medical University
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01764243     History of Changes
Other Study ID Numbers: P211-03
Study First Received: December 26, 2012
Last Updated: February 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Alzheimer's Disease
Nicotinic Acetylcholine Receptor Agonist
Cognitive function
Dementia
Central Nervous System Agents

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Agents
Nicotinic Agonists
Therapeutic Uses
Pharmacologic Actions
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014