CompletedPhase 2

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

Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

SK Chemicals Co., Ltd.

Asset

SK-PC-B70M

Listed sites

Recruiting sites

Enrollment

188

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 IDNCT00443417

Org study IDSMART_II_2006

Timeline

Milestones

Study first posted2007-03-06estimated

Study start2007-04 (month precision)

Primary completion2009-01actual (month precision)

Study completion2009-01actual (month precision)

Last update posted2009-12-09estimated

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

•Age range : 50 ~ 85 years

•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 10 to 26

•AChEI or memantine was discontinued at least 3 months prior to screening

Exclusion criteria

•Patient in mild cognitive impairment (MCI; CDR-SB <2.5)

•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 (12)

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

Other (unclassified)

Global cognition

Memory

Executive function / language

Caregiver / quality of life

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

Memory

1 endpoint

Secondary/protocol endpoint

Delayed Word-Recall Task

Time frame:5 minute

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Verbal Fluency-Categories

Time frame:1 minutes

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

QOL-AD(Quality of Life in Alzheimer's Disease)

Time frame:10 minutes

descriptive