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Low Dose IL2 Immunotherapy in AD

NCT05821153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-04-20

No results posted yet for this study

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

DRUG

Aldesleukin

Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Alireza Faridar · Houston Methodist Neurological Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2022-04-27
Completion
2022-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05821153 on ClinicalTrials.gov