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
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014