Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT01297218
Eligibility Criteria:
Inclusion Criteria:
* Korean men and women who are age 50 or older
* Dementia as determined by DSM-IV criteria
* Probable alzheimer's disease as determined by NINCDS-ADRDA criteria
* K-MMSE score in the range of 10 to 24
* Positive result of PIB-PET imaging (SUV \> 1.5,when comparing the result for the cerebellum with the result for the frontal lobe)
* Voluntarily participating subject who sign the consent form
Exclusion Criteria:
* Subject with psychological diseases (i.e. depression, schizophrenia, bipolar disorder, etc)
* Subject with dementia caused by other than Alzheimer's disease (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severe head trauma, Pick's disease, Huntington's disease, and Parkinson's disease)
* Subject with vascular dementia as determined by the clinical criteria of DSM IV and the imaging criteria of Erkinjuntii
* Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer.
* Subject who have had stroke in 3 months.
* Subject with liver disease (two times higher than normal range of ALT/AST)
* Subject with severe kidney failure (1.5mg/dL of serum creatinine or more)
* Pregnant women or lactating women
* Hemoglobin \< 9.5g/dL for men, \< 9.0 g/dL for women; Total WBC count \< 3000/mm3; Total bilirubin ≥ 3 mg/dL
* Subject who is suspect to have active lung diseases, based on check X-ray result from Visit 1
* Women of childbearing age who reject to practice contraception
* Subject who have been excluded in the subject selection process for this study before
* A platelet count \< 150,000/mm3; PT ≥ 1.5; INR or aPTT ≥ 1.5 X control
* Subject with cancer
* History of alcohol or drug abuse
* Subject who cannot undergo MRI, CT, or PET screening
* Subject who cannot undergo anesthesia or stereotactic brain injection
* Subject who is determined inappropriate by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01297218
Study Brief:
Protocol Section:
NCT01297218