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

Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease

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 Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: SK-PC-B70M

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SKchemicalsI nvestigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1	Drug: SK-PC-B70M; dosage, frequency
Active Comparator: 2; 200mg qd	Drug: SK-PC-B70M; dosage, frequency
Active Comparator: 3; 200mg bid	Drug: SK-PC-B70M; dosage, frequency
Active Comparator: 4; 400mg qd	Drug: SK-PC-B70M; dosage, frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Principal Investigator: Seol Heui Han, MD, PhD, Konkuk University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 5, 2007
• First Submitted That Met QC Criteria: March 5, 2007
• First Posted (Estimate): March 6, 2007

Study Record Updates

• Last Update Posted (Estimate): December 9, 2009
• Last Update Submitted That Met QC Criteria: December 8, 2009
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: SMART_II_2006