Status:
COMPLETED
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01249196
Start Date
May 1 2010
Last Update
November 26 2013
Active Locations (1)
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1
SKChemicals invetigational site
Seoul, South Korea