Alzheimer's Disease
Conditions
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.
Interventions
DRUGSK-PC-B70M
dosage, frequency
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
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale) | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| CDR-SB(Clinical Dementia Rating Sum of Box) | 20 minutes |
| QOL-AD(Quality of Life in Alzheimer's Disease) | 10 minutes |
| Delayed Word-Recall Task | 5 minute |
| Symbol Digit Modalities Test | 5 minutes |
| Digit Backward | 5 minutes |
| MMSE(Mini Mental State Examination) | 10 minutes |
| Digit Cancellation Task | 5 minutes |
| Verbal Fluency-Categories | 1 minutes |
| Concentration / Distractibility | 1 minutes |
| GDS | 10 minutes |
| Maze Task | 3 minutes |
Countries
South Korea
Outcome results
None listed