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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.

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