A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
NCT ID: NCT01249196
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
SK-PC-B70M
for dosage
SK-PC-B70M 200mg bid
SK-PC-B70M
for dosage
SK-PC-B70M 300mg bid
SK-PC-B70M
for dosage
Donepezil
SK-PC-B70M
for dosage
Interventions
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SK-PC-B70M
for dosage
Eligibility Criteria
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Inclusion 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
* 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
55 Years
85 Years
ALL
No
Sponsors
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SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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SKChemicals invetigational site
Seoul, , South Korea
Countries
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Other Identifiers
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SMART_AD_III_2009
Identifier Type: -
Identifier Source: org_study_id
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