NCT00443417CompletedPhase 2
Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
4
Active Comparator
400mg qd
Intervention: SK-PC-B70M (Drug)
1
Placebo Comparator
Intervention: SK-PC-B70M (Drug)
2
Active Comparator
200mg qd
Intervention: SK-PC-B70M (Drug)
3
Active Comparator
200mg bid
Intervention: SK-PC-B70M (Drug)
Outcomes
Primary Outcomes
ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)
Time Frame: 30 minutes
Secondary Outcomes
- MMSE(Mini Mental State Examination)(10 minutes)
- 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)
- Maze Task(3 minutes)
- Digit Cancellation Task(5 minutes)
- Verbal Fluency-Categories(1 minutes)
- Concentration / Distractibility(1 minutes)
- GDS(10 minutes)
Investigators
Study Sites (1)
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