Alzheimer's Disease
Conditions
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.
Interventions
DRUGSK-PC-B70M
for dosage
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) | 45 minutes |
| MMSE (Mini Mental State Examination) | 10 minutes |
| CDR-SB (Clinical Dementia Rating Sum of Box) | 20 minutes |
Countries
South Korea
Outcome results
None listed