NCT02899091进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase I / IIa Clinical Trial for Evaluation of Safety and Potential Therapeutic Effect After Transplantation of CB-AC-02 in Patients With Alzheimer's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The goal of this clinical trial is to evaluate safety and potential therapeutic effect of intraveneously administered CB-AC-02 in patients with Alzheimer's Disease.
详细描述
Subjects will receive either the single or multiple doses of CB-AC-02 to be followed up and evaluated for safety and potential therapeutic effect
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Korean male or female at 50+ years of age at the time of screening visit
- •Diagnosis of Probable Alzheimer disease (probable AD) according to NINCDS-ADRDA criteria at Screening visit
- •Positive for Amyloid on amyloid-ligand PET
- •A subject with the imaging findings of Alzheimer's disease as confirmed by MRI or PET
- •Presence of brain atrophy on brain MRI by visual assessment
- •Presence of reduced brain glucose metabolism in bilateral temporal-parietal lobe on FDG-PET
- •Korea Mini-Mental State Examination (KMMSE) score of 10-26 at time of screening visit
- •Presence of caregiver who can provide information on the subject's condition
- •Subject who has been taking stable dose of Alzheimer medication for last 2 months or more
- •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 Dementia as a result of other disorders [i.e. infectious disease of the central nervous system such as HIV, syphilis, head injury, Creutzfeld-Jacob disease, Picks disease, Huntington's disease, Parkinson's disease, other subdural hematoma, hydrocephalus and structural brain lesions, drug addiction, alcoholism, substance abuse, thyroid disease, parathyroid disease, vitamins and other nutritional deficiencies and vascular etc.]
- •Subject with vascular dementia as determined by the clinical criteria of DSM-IV and the imaging criteria of Erkinkuntii
- •Subject with severe white matter hyperintensities (i.e. ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths)
- •Abnormal laboratory findings at screening visit
- •Subjects who are positive for HIV, syphilis or active HBV, HCV infection
- •Subjects in poor medical condition or subjects with severe cardiovascular, gastrointestinal, pulmonary or endocrinologic disease A. Suspected active active lung disease on chest X-ray at screening visit B. Diagnosis of cancer (except for the subjects who remains in complete remission for 5 years or more )
- •Subject with concurrent unstable psychiatric disorder (i.e. severe depression, or schizophrenia, or bipolar disorder, etc)
- •Pregnant or lactating women
- •Women of childbearing age who reject to practice contraception with one of the following methods
- •Use a condom
- •Use of contraceptive (oral, dermal, or injectable)
- •Use an intra-uterine contraceptive device
- •Subjects with a history of alcohol abuse (>30g/day) or drug abuse
- •Subjects who cannot undergo any of the tests performed in this clinical trial (for example, MRI, CT, PET, CSF study)
- •Subjects with known allergies to protein products (Bovine serum), antibiotics (gentamycin) or DMSO
- •Subjects whom the principal investigator considers inappropriate for participation in theis study
结局指标
主要结局
Number of Adverse Events
时间窗: 48 weeks
Number of subjects with treatment-related adverse events. The safety and tolerability of treatment with CB-AC-02 will be assessed by analysis of adverse events, abnormal findings on physical examinations, standard laboratory tests.
次要结局
- Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging(48 weeks)
- Changes from the baseline in K-MMSE Score(48 weeks)
- Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging(48 weeks)
- Changes of band power in qEEG(48 weeks)
研究者
研究点 (2)
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