Low Dose IL2 Immunotherapy in AD

The Methodist Hospital Research Institute (TMHRI)

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: Aldesleukin

Study type

Interventional

Funder types

Other

Identifiers

NCT05821153

PRO00021747

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

60 to 86 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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%.