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Safety and Efficacy of MT-4666

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01764243
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: MT-4666 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : November 2012
Primary Completion Date : June 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in ADAS-cog-13 [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [ Time Frame: Baseline and Week 24 ]
  2. Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline and Week 24 ]
  3. Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) [ Time Frame: Baseline and Week 24 ]
  4. Change from baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and Week 24 ]
  5. Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline and Week 24 ]
  6. Change from baseline in Modified Crichton Scale [ Time Frame: Baseline and Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764243


Locations
Japan
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

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01764243     History of Changes
Other Study ID Numbers: P211-03
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

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
Neurocognitive Disorders
Mental Disorders