NCT05821153

Low Dose IL2 Immunotherapy in AD

Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 60 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Aldesleukin	Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

Timeline

• Start date: 2019-06-19
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study