A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT01249196
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SK-PC-B70M 200mg bid SK-PC-B70M - SK-PC-B70M 300mg bid SK-PC-B70M - Donepezil SK-PC-B70M - Placebo SK-PC-B70M -
- Primary Outcome Measures
Name Time Method ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) 30 minutes
- Secondary Outcome Measures
Name Time Method MMSE (Mini Mental State Examination) 10 minutes CDR-SB (Clinical Dementia Rating Sum of Box) 20 minutes CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) 45 minutes
Trial Locations
- Locations (1)
SKChemicals invetigational site
🇰🇷Seoul, Korea, Republic of