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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: SK-PC-B70M

• Registration Number: NCT00443417
• Lead Sponsor: SK Chemicals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Study Start: 2007-04
• Status Verified: 2008-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-12-08
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SK-PC-B70M	-
2	SK-PC-B70M	200mg qd
3	SK-PC-B70M	200mg bid
4	SK-PC-B70M	400mg qd

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
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

Trial Locations

Locations (1)

SKchemicalsI nvestigational Site; 🇰🇷 Seoul, Korea, Republic of