Safety and Efficacy of MT-4666

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764243
• Other study ID #: P211-03
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2012
• Last updated: September 24, 2015
• Start date: November 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MT-4666
low dose, high dose
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ADAS-cog-13		Baseline and Week 24	No
Secondary	Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)		Baseline and Week 24	No
Secondary	Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)		Baseline and Week 24	No
Secondary	Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)		Baseline and Week 24	No
Secondary	Change from baseline in Mini-Mental State Examination (MMSE)		Baseline and Week 24	No
Secondary	Change from baseline in Neuropsychiatric Inventory (NPI)		Baseline and Week 24	No
Secondary	Change from baseline in Modified Crichton Scale		Baseline and Week 24	No