- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054208
Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease
A Double-blind, Single-center, Phase 1/2a Clinical Trial to Evaluate the Safety and Exploratory Efficacy of Intraventricular Administrations of NEUROSTEM® Versus Placebo Via an Ommaya Reservoir in Patients With Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
1 stage Inclusion Criteria:
- Korean male or female at 50 -85 years of age
- Diagnosis of Probable Alzheimer type according to NINCDS-ADRDA criteria at Visit 1 (Screening)
- Korea Mini-Mental State Examination (KMMSE) score of 18 - 26 at Visit 1 (Screening)
- Positive for Amyloid on PIB-PET or Florbetaben PET
- A subject who is informed of the clinical trial and signs a consent form (if unable to sign, a consent from a legally acceptable representative is required)
2 stage Inclusion Criteria:
- Korean male or female at 50 -85 years of age
- Diagnosis of Probable Alzheimer type or mild cognitive impairment due to Alzheimer's disease (stage A) according to NIA-AA criteria at Visit 1(Screening)
- Korea Mini-Mental State Examination (KMMSE) score of over 18 at Visit 1 (Screening)
- Positive for Amyloid on Florbetaben PET
- A subject with neurodegeneration (mild atrophy of the brain) as confirmed by MRI
- A subject who is informed of the clinical trial and signs a consent form (if unable to sign, a consent from a legally acceptable representative is required)
Exclusion Criteria:
- Concurrent mental disorder (such as schizophrenia, depression, bi-polar diseases or others) aside from dementia
- Concurrent dementia as a result of other neurodegenerative disorders (due to infectious disease of the central nervous system such as HIV, syphilis), head injury, Creutzfeld-Jacob disease, Pick's disease, Huntington's disease, or Parkinson's disease
- Diagnosis of severe white matter hyperintensitivity (WMH) according to CREDOS (Clinical REsearch Center for Dementia of South Korea), which is defined as ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths
- History of stroke within 3 months prior to study enrollment
- Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
- Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
- Pregnant or lactating females
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
- Suspected active lung disease based on chest X-ray at Visit 1
- Woman of childbearing age who refuses to practice medically acceptable contraceptive method (post menopausal patient with no menstruation for at least 12 months is considered as infertile)
- History of screening failure for the clinical trial of NEUROSTEM® in the past 6 months
- Participation in another clinical trial in the past 3 months prior to the beginning (Week 0) of this clinical trial
- Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of < 150,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
- Diagnosis of cancer (of any body system, including brain tumor)
- Substance/alcohol abuse
- Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
- A subject in whom Ommaya reservoir insertion is considered difficult
- Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NEUROSTEM (hUCB-MSCs)- low dose
human umbilical cord blood derived mesenchymal stem cells Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
|
Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
Other Names:
|
Experimental: NEUROSTEM (hUCB-MSCs) - high dose
human umbilical cord blood derived mesenchymal stem cells High dose: 3 x 10^7 cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
|
Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
Other Names:
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Placebo Comparator: Placebo
normal saline 2mL, doses separated by 4 weeks for a total of 3 doses
|
Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: 24 weeks after the first dose
|
Number of subjects with adverse event, number of subjects with normal range of vital signs, mixed lymphocyte reaction result, and laboratory examination result
|
24 weeks after the first dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline in ADAS-Cog
Time Frame: 24 weeks after the first dose
|
Alzheimer's Disease assessment Scale-Cognitive Subscale
|
24 weeks after the first dose
|
Change from the baseline in S-IADL
Time Frame: 24 weeks after the first dose
|
Seoul Instrumental Activities of Daily Living
|
24 weeks after the first dose
|
Change from the baseline in K-MMSE
Time Frame: 24 weeks after the first dose
|
Mini Mental State Exmination Korean version
|
24 weeks after the first dose
|
Change from the baseline in CGA-NPI
Time Frame: 24 weeks from the first dose
|
Caregiver-administered Neuropsychiatric Inventory
|
24 weeks from the first dose
|
ADAS-Cog Response Rate
Time Frame: 24 weeks after the first dose
|
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
|
24 weeks after the first dose
|
Change in CDR-SOB
Time Frame: 24 weeks after the first dose
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Clinical Dementia Rating-Sum of Box
|
24 weeks after the first dose
|
Change in Florbetaben-PET
Time Frame: 24 weeks after the first dose
|
Florbetaben - Pittsburgh Compound B-positron emission tomography
|
24 weeks after the first dose
|
Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
Time Frame: 24 weeks after the first dose
|
fluorodeoxyglucose positron emission tomography
|
24 weeks after the first dose
|
Change in CIBIC-plus
Time Frame: 24 weeks after the first dose
|
The Clinician's Interview Based Impression of Change-plus
|
24 weeks after the first dose
|
Change from baseline in MRI (DTI mapping)
Time Frame: 24 weeks after the first dose
|
MRI Analysis
|
24 weeks after the first dose
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Change from the baseline in CSF biomarkers
Time Frame: 24 weeks after the first dose
|
biomakrer analysis
|
24 weeks after the first dose
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wonil Oh, MD, PhD, Medipost Co Ltd.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-CR-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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