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NCT06096090 · ClinicalTrials.gov registry record · Phase 2
Phase II Clinical Trial of Interleukin-2 in AD
A Phase 2 study of Alzheimer Disease, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06096090 is a Phase 2 study of Alzheimer Disease that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 40 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06096090, a Phase 2 study of Alzheimer Disease, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Interleukin-2
Study Locations (1)
Texas
- Houston Methodist Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096090
The ClinicalTrials.gov registry entry for NCT06096090 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06096090 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06096090 about?
NCT06096090 is a clinical study titled "Phase II Clinical Trial of Interleukin-2 in AD". Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing...
What is the current status of trial NCT06096090?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-01-01. Estimated completion is 2025-12-30.
What conditions does trial NCT06096090 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06096090?
The interventions under investigation include: Placebo (DRUG), Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT06096090?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096090 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.