Back to resultsA Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 3
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:
- 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 of 10 to 26 and CDR of 1 or 2
- AChEI or memantine was not taken at least 3 months prior to screening
Exclusion Criteria:
- 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
- SKChemicals invetigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Other
Arm Label
Placebo
SK-PC-B70M 200mg bid
SK-PC-B70M 300mg bid
Donepezil
Arm Description
Outcomes
Primary Outcome Measures
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Secondary Outcome Measures
CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
MMSE (Mini Mental State Examination)
CDR-SB (Clinical Dementia Rating Sum of Box)
Full Information
NCT ID
NCT01249196
First Posted
November 23, 2010
Last Updated
November 25, 2013
Sponsor
SK Chemicals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01249196
Brief Title
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SK-PC-B70M 200mg bid
Arm Type
Experimental
Arm Title
SK-PC-B70M 300mg bid
Arm Type
Experimental
Arm Title
Donepezil
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
SK-PC-B70M
Intervention Description
for dosage
Primary Outcome Measure Information:
Title
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
Time Frame
45 minutes
Title
MMSE (Mini Mental State Examination)
Time Frame
10 minutes
Title
CDR-SB (Clinical Dementia Rating Sum of Box)
Time Frame
20 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:
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 of 10 to 26 and CDR of 1 or 2
AChEI or memantine was not taken at least 3 months prior to screening
Exclusion Criteria:
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
Facility Information:
Facility Name
SKChemicals invetigational site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
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