Low Dose IL2 Immunotherapy in AD

Completed · Phase 1

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT05821153

Run by

The Methodist Hospital Research Institute

People needed

8

Starts

2019-06-19

Expected to finish

2022-04-27

Last updated by the study team

2023-04-20

Who can join

Age: 60 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.
• 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.

You may not qualify if…

• 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%.

Where it is running

• Alireza Faridar — Houston, Texas, United States

Full record on ClinicalTrials.gov

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