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Completed

NCT Number: NCT01764243

Safety and Efficacy of MT-4666

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kanto, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-4666

Drug

low dose, high dose

Placebo

Drug

Primary outcomes

  1. Change from baseline in ADAS-cog-13

    Time frame: Baseline and Week 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2013
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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