Low Dose IL2 Immunotherapy in AD

Phase 1

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT05821153
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the safety and the tolerability of IL-2 in AD patients	4 months treatment phase	Primary endpoints: - Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).

Secondary Outcome Measures

Name	Time	Method
To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.	4 months treatment phase	Secondary endpoints: - Change in Treg percentage out of total # of CD4 cells from baseline to month 4

Trial Locations

Locations (1)

Alireza Faridar; 🇺🇸 Houston, Texas, United States