NCT04482413尚未招募2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease
Nature Cell Co. Ltd.0 个研究点目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- SUVR (Standard Uptake Value Ratio)
研究概览
简要总结
This is a phase 2b randomized, double-blind, Placebo-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem vs. Placebo treatment in patients with mild Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem every 4 weeks from Week 0 to Week 36. On the other hand, patients who are randomized into the placebo control group will receive Placebo every 4 weeks from Week 0 to Week 36. After the final administration, patients will be scheduled for two follow-up visits, at Weeks 44 and 52, to assess efficacy and safety endpoints.
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
- Double (Participant, 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
- •Male or female patients aged 50 and above at the time of signing the Informed Consent Form
- •Patients who can understand and provide written informed consent (assent)
- •Patients who have a diagnosis of probable mild Alzheimer's Disease(AD) according to the National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria within one year of the start of treatment
- •Patients who have an MMSE Score of 20 to 24 at screening
- •Patients who have a Clinical Dementia Rating (CDR)-Global Score of 0.5 to 1 at baseline
- •Patients who have any FDA-approved AD medication (donepezil, galantamine, memantine, rivastigmine or any combination) since their AD diagnosis receiving a stable dose of medical teratment for at least 12 weeks prior to Screening and were to stay on a stable dose during the study
- •Patients who have one (or more) identified adult caregiver (study partner) who is able to read, understand, and speak the designated language at the study site; who either lives with the subject or sees the subject for ≥2 hours/day ≥4 days/week; and who agrees to accompany the subject to each study visit and to participate in the subject's clinical assessments
- •Patients who have a diagnosis of probable mild AD according to Amyloid PET scan at screening
排除标准
- •Female patients who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
- •Patients who have signs of delirium
- •Patients who have had a cortical stroke within the preceding 2 years
- •Patients who have a prolonged QTc interval at screening; >450 msec for males or >470 msec for females
- •Patients who have a diagnosis of severe white matter hyperintensity (WMH), which is defined as ≥25mm of the deep white matter and ≥10mm of the periventricular capping/banding in lengths
- •Patients who have a diagnosis of dementia or cause of cognitive impairment other than AD
- •Patients who have a significant abnormal result in laboratory tests, in the opinion of the investigator
- •Patients who have participated in any investigational drug, stem cell therapy, or device trial within the previous 3 months at screening
- •Patients with any current psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the subject´s ability to complete the study
- •Patients who are known to have autosomal dominant mutation-associated presenile AD
- •Patients who show signs of Acquired Immunodeficiency Syndrome (AIDS), Hepatitis B Virus (HBV), Hepatitis C (HCV), Venereal Disease Research Laboratory (VDRL)
- •Patients who have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart
- •Patients who have >4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, or evidence of a prior microhemorrhage as assessed by MRI
- •Patients who have history of malignant cancer within the last 5 years (The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer)
- •Patients who have suspected active lung disease based on chest X-ray
- •Patients who are hypersensitive to fetal bovine serum or penicillin
- •Patients who are currently using immunosuppressants, cytotoxic drug, corticosteroids or similar steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis (exceptions allowed include; regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy)
- •Patients for whom the investigator judges the liposuction may cause a problem
研究组 & 干预措施
Treatment
Experimental
Treatment group will be administered via intravenously AstroStem which consists of two syringes and each syringe contains 2.0 x 10^8 cells / 20 mL of saline with 30% auto-serum.
干预措施: AstroStem (Drug)
Placebo Control
Placebo Comparator
Placebo control group will receive AstroStem Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
SUVR (Standard Uptake Value Ratio)
时间窗: Baseline and 52 Weeks
Standard Uptake Value Ratio (SUVR) of the Amyloid PET scan
次要结局
- CDR-SB score (Clinical Dementia Rating Sum of Boxes)(Baseline and 52 Weeks)
- ADAS-Cog-11 score (Alzheimer's Disease assessment Scale-Cognitive Subscale (11 items))(Baseline and 52 Weeks)
- MMSE (Mini-mental status examination)(Baseline and 52 Weeks)
- ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory)(Baseline and 52 Weeks)
- C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline and 52 Weeks)
- NPI (Neuropsychiatric Inventory)(Baseline and 52 Weeks)
- Treatment related Adverse Events(Baseline and 52 Weeks)
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