Low Dose IL2 Immunotherapy in AD

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Alzheimer Disease

Clinical Trial Details

NCT number	NCT05821153
Study type	Interventional
Source	The Methodist Hospital Research Institute
Contact
Status	Completed
Phase	Phase 1
Start date	June 19, 2019
Completion date	April 27, 2022

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