NCT02054208已完成1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity (DLT), and exploratory efficacy of three repeated intraventricular administrations of NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.
详细描述
The study is divided into the 2 stages: dose-escalation in stage 1 and randomized and multiple-dose cohort parallel design in stage 2.The target population for enrollment in this study is patients with mild to moderate Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Number of subjects with adverse events
时间窗: 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
次要结局
- Change from the baseline in S-IADL(24 weeks after the first dose)
- Change from the baseline in ADAS-Cog(24 weeks after the first dose)
- Change from the baseline in K-MMSE(24 weeks after the first dose)
- Change from the baseline in CGA-NPI(24 weeks from the first dose)
- ADAS-Cog Response Rate(24 weeks after the first dose)
- Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)(24 weeks after the first dose)
- Change from baseline in MRI (DTI mapping)(24 weeks after the first dose)
- Change from the baseline in CSF biomarkers(24 weeks after the first dose)
- Change in CDR-SOB(24 weeks after the first dose)
- Change in Florbetaben-PET(24 weeks after the first dose)
- Change in CIBIC-plus(24 weeks after the first dose)
研究者
研究点 (1)
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