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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: Completed Phase 1 study, sponsored by The Methodist Hospital Research Institute.
NCT05821153 is a Phase 1 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary endpoints: \- Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).
Interventions
- DRUG Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 1 |
What the finished NCT05821153 record still lists
NCT05821153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Aldesleukin is the first listed.
NCT05821153 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05821153's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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