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

This study has been completed.
Sponsor:
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00443417
First received: March 5, 2007
Last updated: December 8, 2009
Last verified: January 2008
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: SK-PC-B70M
Phase 2

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

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:
  • 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 ]
  • QOL-AD(Quality of Life in Alzheimer's Disease) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • Delayed Word-Recall Task [ Time Frame: 5 minute ] [ Designated as safety issue: No ]
  • Symbol Digit Modalities Test [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Digit Backward [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Maze Task [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
  • Digit Cancellation Task [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Verbal Fluency-Categories [ Time Frame: 1 minutes ] [ Designated as safety issue: No ]
  • Concentration / Distractibility [ Time Frame: 1 minutes ] [ Designated as safety issue: No ]
  • GDS [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: April 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00443417

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

No publications provided

Responsible Party: Clinical research team, SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00443417     History of Changes
Other Study ID Numbers: SMART_II_2006
Study First Received: March 5, 2007
Last Updated: December 8, 2009
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 August 28, 2014