We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00443417
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : December 9, 2009
Information provided by:
SK Chemicals Co.,Ltd.

Brief Summary:
The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: SK-PC-B70M Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease
Study Start Date : April 2007
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: SK-PC-B70M
dosage, frequency
Active Comparator: 2
200mg qd
Drug: SK-PC-B70M
dosage, frequency
Active Comparator: 3
200mg bid
Drug: SK-PC-B70M
dosage, frequency
Active Comparator: 4
400mg qd
Drug: SK-PC-B70M
dosage, frequency

Primary Outcome Measures :
  1. ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. MMSE(Mini Mental State Examination) [ Time Frame: 10 minutes ]
  2. CDR-SB(Clinical Dementia Rating Sum of Box) [ Time Frame: 20 minutes ]
  3. QOL-AD(Quality of Life in Alzheimer's Disease) [ Time Frame: 10 minutes ]
  4. Delayed Word-Recall Task [ Time Frame: 5 minute ]
  5. Symbol Digit Modalities Test [ Time Frame: 5 minutes ]
  6. Digit Backward [ Time Frame: 5 minutes ]
  7. Maze Task [ Time Frame: 3 minutes ]
  8. Digit Cancellation Task [ Time Frame: 5 minutes ]
  9. Verbal Fluency-Categories [ Time Frame: 1 minutes ]
  10. Concentration / Distractibility [ Time Frame: 1 minutes ]
  11. GDS [ Time Frame: 10 minutes ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443417

Korea, Republic of
SKchemicalsI nvestigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: Seol Heui Han, MD, PhD Konkuk University Hospital

Responsible Party: Clinical research team, SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00443417     History of Changes
Other Study ID Numbers: SMART_II_2006
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: January 2008

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