Status:
COMPLETED
A 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:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00443417
Start Date
April 1 2007
End Date
January 1 2009
Last Update
December 9 2009
Active Locations (1)
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1
SKchemicalsI nvestigational Site
Seoul, South Korea