A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
NCT ID: NCT00443417
Last Updated: 2009-12-09
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2007-04-30
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
SK-PC-B70M
dosage, frequency
2
200mg qd
SK-PC-B70M
dosage, frequency
3
200mg bid
SK-PC-B70M
dosage, frequency
4
400mg qd
SK-PC-B70M
dosage, frequency
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SK-PC-B70M
dosage, frequency
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 10 to 26
* AChEI or memantine was discontinued 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
55 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
SK Chemicals Co.,Ltd.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Seol Heui Han, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SKchemicalsI nvestigational Site
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMART_II_2006
Identifier Type: -
Identifier Source: org_study_id