Safety and Efficacy of MT-4666

September 24, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in ADAS-cog-13
Time Frame: Baseline and Week 24
Baseline and Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 26, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P211-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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