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NCT05821153 · ClinicalTrials.gov registry record · Phase 1
Low Dose IL2 Immunotherapy in AD
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05821153 is a Phase 1 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 8 participants.
The verdict
NCT05821153, a Phase 1 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
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.
Interventions
- DRUG Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05821153
The ClinicalTrials.gov registry entry for NCT05821153 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aldesleukin is the first listed.
NCT05821153 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05821153 about?
NCT05821153 is a clinical study titled "Low Dose IL2 Immunotherapy in AD". 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 d...
What is the current status of trial NCT05821153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-06-19. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT05821153?
The interventions under investigation include: Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT05821153?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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