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

This study has been completed.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
First received: November 23, 2010
Last updated: November 25, 2013
Last verified: November 2010
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Condition Intervention Phase
Alzheimer's Disease
Drug: SK-PC-B70M
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
  • MMSE (Mini Mental State Examination) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • CDR-SB (Clinical Dementia Rating Sum of Box) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: May 2010
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 200mg bid Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 300mg bid Drug: SK-PC-B70M
for dosage
Donepezil Drug: SK-PC-B70M
for dosage


Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01249196

Korea, Republic of
SKChemicals invetigational site
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
  More Information

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01249196     History of Changes
Other Study ID Numbers: SMART_AD_III_2009 
Study First Received: November 23, 2010
Last Updated: November 25, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 26, 2016