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CompletedPhase 3

A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

Asset

SK-PC-B70M

Listed sites

1

Recruiting sites

-

Enrollment

256

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

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 IDNCT01249196
Org study IDSMART_AD_III_2009

Timeline

Milestones

Study start2010-05 (month precision)
Study first posted2010-11-29estimated
Primary completion2013-08actual (month precision)
Last update posted2013-11-26estimated

Assets

Drug assets

SK-PC-B70M

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

•Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
•MRI within the last 12 months consistent with a diagnosis of AD
•MMSE score of 10 to 26 and CDR of 1 or 2
•AChEI or memantine was not taken at least 3 months prior to screening

Exclusion criteria

•Other central nervous disease
•Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
•T.I.A or Major infarction within the last 12 months
•Any serious disorder that could limit the ability of the patient to participate in the study
•COPD or asthma
•Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Endpoints (4)

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
3
Caregiver / quality of life
1

Global cognition

3 endpoints
Primary/protocol endpoint

ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)

Time frame:30 minutes

ADAS-Cog

descriptive

Secondary/protocol endpoint

MMSE (Mini Mental State Examination)

Time frame:10 minutes

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

CDR-SB (Clinical Dementia Rating Sum of Box)

Time frame:20 minutes

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

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)

Time frame:45 minutes

descriptive

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.