A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 55-90 years at the time of signing consent
- •Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi/Lecanemab or Kisunla/Donanemab) for at least 6 months prior to the infusion visit.
- •MMSE score 20-
- •Patients must be able to consent.
- •Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study.
排除标准
- •Dementia other than AD
- •Patient with severe depression. Patients with controlled depression are allowed to participate.
- •Inability to independently provide informed consent is considered exclusionary per protocol requirements
- •Recent history of substance abuse
- •History of bleeding disorders, HIV, HCV or HBV
- •Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.
- •Uncontrolled medical conditions (hypertension, diabetes, unstable angina or MI within 1 year prior to screening)
- •History of bleeding disorder
- •Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.
- •Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study
- •Be premenopausal
研究组 & 干预措施
Mesenchymal Stem Cell Infusion
Patients will receive one infusion of 25 million of human mesenchymal stem cells in the vein.
干预措施: human Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)
时间窗: Baseline, Week 16, Week 32, and Week 48
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) is a validated performance-based instrument used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. The scale evaluates multiple cognitive domains, including memory, reasoning, language, orientation, ideational praxis, and constructional praxis. Spoken language, language comprehension, word-finding ability, and the ability to remember instructions are also assessed. Scores range from 0 to 70, with higher scores indicating greater cognitive impairment.
次要结局
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL)(Baseline, Week 16, Week 32, and Week 48)
研究者
Bernard (Barry) Baumel
Associate Professor of Clinical Neurology
University of Miami