The Long-Term Safety and Efficacy Follow-up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD

Date de début de l'étude : 1 mars 2012

TEST GROUP Inclusion Criteria: Subjects who have enrolled and completed the Phase I cliical trial: The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease Subjects who are willing to participate in the study and sign the consent form Exclusion Criteria: Females who are pregnant or nursing Subjects who have participated in another clinical study within the 3 months prior to the initiation of this study Subjects who are restricted from undergoing exams perfomed during the study (i.e. MRI, CT, or PET screening) Subjects who the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above CONTROL GROUP Inclusion Criteria: Patients with a moderate alzheimer's disease, diagnosed with a dementia of alzheimer's type, according to the DSM-VI and NINCDS-ADRDA criteria, and shows amyloid-positive in a PIB-PET Exclusion Criteria: Subjects with a psychological disease (i.e. depression, schizophrenia, bipolar disorder, etc) Subjects with a dementia caused by other degenerative neurological diseases (infection of the CNS, such as HIV or Syphilis), head trauma, Creutzfeld-Jacob disease, Pick's disease, Huntington's disease, and Parkinson's disease) Subjects with a vascular dementia as determined by the clinical criteria of DSM IV and the imaging criteria of Erkinjuntii Subjects with severe white matter hyperintensities (WMH); Severe WMH is defined as, according to Clinical Research Center for Dementia of South Korea, a condition in which the deep white matter is 25 mm or greater and the periventricular capping/banding is 10 mm or greater in lengths. Subjects with a history of stroke within the 3 months prior to the study enrollment Subjects with a severe liver disease (ALT/AST values are higher than twice the normal range) Subjects with a severe renal disease (1.5mg/dL or more of serum creatinine) Pregnant or lactating women Subjects with abnormal findings of the clinical laboratory values at Visit 1: Hemoglobin < 9.5g/dL in male < 9.0 g/dL in female Total WBC count < 3000/mm3 Total bilirubin ≥ 3 mg/dL Subjects with a suspected active lung disease, based on the chest X-ray result at Visit 1 Females of childbearing age who does not practice medically acceptable method of contraception during the study Subjects who have previously failed Screening for participation in this study Subjects who have participated in another clinical study within the 3 months prior to the initiation of this study Subjects with a bleeding disorder (platelet count < 150,000/mm3; PT ≥ 1.5; INR or aPTT ≥ 1.5 X control Subjects with a cancer (including brain tumor) Subjects with a history of alcohol or drug abuse Subjects who are restricted from undergoing exams perfomed during the study (i.e. MRI, CT, or PET screening) Patients who the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above