Safety Study of MT-4666 in Subjects With Alzheimer's Disease | NCT02327182

Studies
Safety Study of MT-4666 in Subjects With Alzheimer's Disease

NCT02327182

Sponsor

Tanabe Pharma Corporation

Status

Terminated

Last Update Posted

Nov 13, 2015Estimated

Enrollment

117Actual

Phase

Phase 3

Conditions

Alzheimer's Disease

Interventions

MT-4666

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated due to the benefit-risk balance of MT-4666.

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 23, 2014

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2015

Last Update Posted Date

Nov 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MT-4666 low dose	Experimental	Low Dose, Tablet, Once Daily, For 52 Weeks	Drug: MT-4666
MT-4666 high dose	Experimental	High Dose, Tablet, Once Daily, For 52 Weeks	Drug: MT-4666

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MT-4666	Drug		MT-4666 high dose MT-4666 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS)		Up to week 56

Secondary Outcomes

Measure	Description	Time Frame
Change in Mini Mental State Examination (MMSE)		baseline to Week 52
Change in Neuropsychiatric Inventory (NPI) total score		baseline to Week 52

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
Appropriate caregiver available
Subject living at home or in facilities who do not require continuous (24-hour) nursing care.

Exclusion Criteria:

Diagnosis of any other disease which may cause dementia
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
complication of hepatic disorder or renal dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu Nakamura, M.D., Ph.D.	Kagawa University School of Medicine	Study Director
Kazuoki Kondo, M.D.	Tanabe Pharma Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site		Osaka	Kansai		Japan

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided