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

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: SK-PC-B70M

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249196

SMART_AD_III_2009

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: SK-PC-B70M

SK-PC-B70M 200mg bid

Experimental group

Treatment:

Drug: SK-PC-B70M

SK-PC-B70M 300mg bid

Experimental group

Treatment:

Drug: SK-PC-B70M

Donepezil

Other group

Treatment:

Drug: SK-PC-B70M