Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- To assess the safety and the tolerability of IL-2 in AD patients
研究概览
简要总结
Neuroinflammation is a significant component of Alzheimer disease (AD). Our data demonstrated compromised regulatory T cells (Tregs) phenotype and suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing in disease progression. Low dose interleukin-2 (IL-2) is now viewed as a very promising immunoregulatory drug having the capacity to selectively expand and restore functional Tregs. This study is a phase I open-label study to assess subcutaneous interleukin-2 (IL2) safety and potential efficacy as a Treg inducer in AD. 8 Alzheimer dementia patients with mild clinical dementia will be recruited into the study. The baseline cognitive status will be evaluated in these patients. Monthly five-day-courses of subcutaneous IL2 (1MUI/day) will be administered for a total of 4 months. Changes in Tregs from pre to post injections will be measured during the study period. The expected time participants will be in the study is 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
- •Male or female age 60 to 86 years
- •Clinical dementia rating scale of 1
- •Total bilirubin less than or equal to 1.5mg/dL
- •Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0gm/dL
- •Serum creatinine less than 1.5 mg/dL
- •English language speaking
- •A family member or caretaker who is expected to be consistently available, administer study drug and attend study visits throughout the study.
排除标准
- •Serious, active bacterial, fungal or viral infection
- •Severe pulmonary dysfunction. FEV1 and FVC less than 40% of predicted (or 3 SD below normal) at baseline, If a pulmonary function test is clinically indicated. Hx of intubation for >72 hours.
- •Severe cardiac dysfunction defined as left ventricular ejection fraction <40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
- •Hypersensitivity or allergy to IL-2
- •Bowel ischemia/perforation, GI bleeding requiring surgery
- •Resistant seizures, history of coma or toxic psychosis lasting >48 hours
- •Patients with White Blood Count (WBC) <4,000/mm3; platelets <100,000/mm3; hematocrit (HCT) <30%.
结局指标
主要结局
To assess the safety and the tolerability of IL-2 in AD patients
时间窗: 4 months treatment phase
Primary endpoints: \- Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).
次要结局
- To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.(4 months treatment phase)
研究者
Alireza Faridar
Assistant Professor
The Methodist Hospital Research Institute