CompletedPhase 2

Safety and Efficacy of MT-4666

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

Lead sponsor

Tanabe Pharma Corporation

Asset

MT-4666

Listed sites

Recruiting sites

Enrollment

450

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR-SB ≥2•MMSE 10-24•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01764243

Org study IDP211-03

Timeline

Milestones

Study start2012-11 (month precision)

Study first posted2013-01-09estimated

Primary completion2015-06actual (month precision)

Study completion2015-07actual (month precision)

Last update posted2015-09-28estimated

Assets

Drug assets

MT-4666

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Change from baseline in ADAS-cog-13

Time frame:Baseline and Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Time frame:Baseline and Week 24

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)

Time frame:Baseline and Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline and Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change from baseline in Neuropsychiatric Inventory (NPI)

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in Modified Crichton Scale

Time frame:Baseline and Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.