NCT06781333招募中2 期
A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.
Bernard (Barry) Baumel2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年4月29日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Neuropsychiatric Inventory
研究概览
简要总结
The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe 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
- •A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- •Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease
- •A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders
- •Onset of behavioral symptoms at least 4 weeks prior to screening.
- •Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.
- •Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.
- •Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.
排除标准
- •Dementia other than AD
- •Patient with severe depression. Patient with controlled depression is allowed to participate.
- •Recent history of substance abuse
- •History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus
- •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 Myocardial Infarction 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
hMSC group
Experimental
Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.
干预措施: hMSC (Biological)
结局指标
主要结局
Neuropsychiatric Inventory
时间窗: Up to 12 weeks.
Score ranges from 0-12, higher scores indicate a worse psychiatric outcome
次要结局
- Change in antipsychotic medications dosage(Baseline to 12 weeks)
- Change in number of antipsychotic medications(Baseline to 12 weeks)
研究者
Bernard (Barry) Baumel
Associate Professor of Neurology
University of Miami
研究点 (2)
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