Clinical trial NCT04954534: Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®
Official title: Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Medipost Co Ltd.
First posted: 2021-07-08
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial


Eligibility criteria: Inclusion Criteria:

1. Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®
2. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)

Exclusion Criteria:

1. History of stroke within 3 months prior to study enrollment
2. Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
3. Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
4. Abnormal Laboratory findings at Visit 1

   * Hemoglobin \< 9.5 g/dL for male and \<9.0 g/dL for female
   * Total WBC Count \< 3000/mm3
   * Total Bilirubin \>= 3 mg/dL
5. Suspected active lung disease based on chest X-ray at Visit 1
6. Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of \< 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
7. Diagnosis of cancer (of any body system, including brain tumor)
8. Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
9. Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Primary outcomes:
measure: Change from the baseline in ADAS-Cog
timeFrame: 4weeks,8weeks,12weeks,24 weeks after the first dose
Secondary outcomes:
measure: Change in CDR-SOB
timeFrame: 24 weeks after the first dose
measure: Change from the baseline in K-MMSE(korean version)
timeFrame: 24 weeks after the first dose
measure: Change from the baseline in CGA-NPI
timeFrame: 24 weeks after the first dose
measure: Change from the baseline in SIB
timeFrame: 24 weeks after the first dose
measure: ADAS-Cog Response Rate
timeFrame: The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline
measure: Change in CIBIC-plus
timeFrame: 24 weeks after the first dose
measure: Change from the baseline in CSF biomarkers
timeFrame: 24 weeks after the first dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk L. Na, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: