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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01249196
First received: November 23, 2010
Last updated: November 25, 2013
Last verified: November 2010

November 23, 2010
November 25, 2013
May 2010
August 2013   (final data collection date for primary outcome measure)
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249196 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: SK-PC-B70M
for dosage
  • Placebo Comparator: Placebo
    Intervention: Drug: SK-PC-B70M
  • Experimental: SK-PC-B70M 200mg bid
    Intervention: Drug: SK-PC-B70M
  • Experimental: SK-PC-B70M 300mg bid
    Intervention: Drug: SK-PC-B70M
  • Donepezil
    Intervention: Drug: SK-PC-B70M
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01249196
SMART_AD_III_2009
Not Provided
SK Chemicals Co.,Ltd.
SK Chemicals Co.,Ltd.
Not Provided
Not Provided
SK Chemicals Co.,Ltd.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP