Skip to main content
Delfa

← Trials/Trial dossier/NCT02327182

TerminatedPhase 3

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

A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

Asset

MT-4666

Listed sites

1

Recruiting sites

-

Enrollment

117

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-24

Primary endpoint

•Safety of 2 fixed doses of EVP-6124

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 IDNCT02327182
Org study IDP211-05

Timeline

Milestones

Study start2014-12 (month precision)
Study first posted2014-12-30estimated
Primary completion2015-09actual (month precision)
Study completion2015-10actual (month precision)
Last update posted2015-11-13estimated

Assets

Drug assets

MT-4666

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (3)

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
1
Behavior / neuropsychiatric
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change in Mini Mental State Examination (MMSE)

Time frame:baseline to Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) total score

Time frame:baseline to Week 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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)

Time frame:Up to week 56

event count, event

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.