Back to resultsA Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SK-PC-B70M
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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
Sites / Locations
- SKchemicalsI nvestigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
200mg qd
200mg bid
400mg qd
Outcomes
Primary Outcome Measures
ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)
Secondary Outcome Measures
MMSE(Mini Mental State Examination)
CDR-SB(Clinical Dementia Rating Sum of Box)
QOL-AD(Quality of Life in Alzheimer's Disease)
Delayed Word-Recall Task
Symbol Digit Modalities Test
Digit Backward
Maze Task
Digit Cancellation Task
Verbal Fluency-Categories
Concentration / Distractibility
GDS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00443417
Brief Title
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Official Title
Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Description
200mg qd
Arm Title
3
Arm Type
Active Comparator
Arm Description
200mg bid
Arm Title
4
Arm Type
Active Comparator
Arm Description
400mg qd
Intervention Type
Drug
Intervention Name(s)
SK-PC-B70M
Intervention Description
dosage, frequency
Primary Outcome Measure Information:
Title
ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
MMSE(Mini Mental State Examination)
Time Frame
10 minutes
Title
CDR-SB(Clinical Dementia Rating Sum of Box)
Time Frame
20 minutes
Title
QOL-AD(Quality of Life in Alzheimer's Disease)
Time Frame
10 minutes
Title
Delayed Word-Recall Task
Time Frame
5 minute
Title
Symbol Digit Modalities Test
Time Frame
5 minutes
Title
Digit Backward
Time Frame
5 minutes
Title
Maze Task
Time Frame
3 minutes
Title
Digit Cancellation Task
Time Frame
5 minutes
Title
Verbal Fluency-Categories
Time Frame
1 minutes
Title
Concentration / Distractibility
Time Frame
1 minutes
Title
GDS
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seol Heui Han, MD, PhD
Organizational Affiliation
Konkuk University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SKchemicalsI nvestigational Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
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