NCT05821153

Low Dose IL2 Immunotherapy in AD

Completed Phase 1 Last updated 20 April 2023

What this trial tests

Phase 1 trial testing Aldesleukin in Alzheimer Disease in 8 participants. Completed in 27 April 2022.

Timeline

19 June 2019

Primary endpoint
27 April 2022

27 April 2022

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	19 June 2019
Primary completion	27 April 2022
Estimated completion	27 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Aldesleukin (ALDESLEUKIN) — full drug profile →

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

The Methodist Hospital Research Institute

Who can join

Adults 60 to 86, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's Disease: Novel Targets and Investigational Drugs for Disease Modification.
   Cummings JL, Osse AML, Kinney JW. · · 2023 · cited 75× · PMID 37728864 · DOI 10.1007/s40265-023-01938-w
2. NF-κB Pathway and Its Inhibitors: A Promising Frontier in the Management of Alzheimer's Disease.
   Sivamaruthi BS, Raghani N, Chorawala M, Bhattacharya S, et al · · 2023 · cited 62× · PMID 37761028 · DOI 10.3390/biomedicines11092587
3. Overlapping Neuroimmune Mechanisms and Therapeutic Targets in Neurodegenerative Disorders.
   De Marchi F, Munitic I, Vidatic L, Papić E, et al · · 2023 · cited 26× · PMID 37893165 · DOI 10.3390/biomedicines11102793
4. A phase 1 open-label pilot study of low-dose interleukine-2 immunotherapy in patients with Alzheimer's disease.
   Faridar A, Eid AM, Thome AD, Zhao W, et al · · 2023 · cited 17× · PMID 37968718 · DOI 10.1186/s40035-023-00387-5
5. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
6. The role of regulatory T cells in central nervous system diseases in dogs: fighting with a double-edged sword toward translational discoveries.
   Benavides ED, Fuentes MDM, Bell L, Benedicenti L, et al · · 2025 · PMID 41268269 · DOI 10.62347/rtgf8675