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NCT07651319 · ClinicalTrials.gov registry record · Phase 1
Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07651319 is a Phase 1 study that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 30 participants.
The verdict
NCT07651319, a Phase 1 study, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited. Growing evidence suggests that inflammation in the brain and the body plays a key role in the onset and progression of AD. In particular, immune cells called regulatory T cells (Tregs), which normally help control inflammation, are impaired in AD individuals. This leads to increased activity of harmful immune pathways that worsen brain injury. Interleukin-2 (IL-2) is a drug that can restore the function of Tregs. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, are a class of drugs currently used to treat diabetes and obesity. Beyond their metabolic effects, GLP-1RAs also reduce inflammation, protect brain cells, and improve cellular energy balance. Laboratory studies, including our own, show that combining IL-2 with semaglutide has stronger effects than either drug alone. Together, they enhance Treg function, dampen harmful inflammatory responses, and improve cell survival. These findings support testing IL-2 plus semaglutide as a novel combination therapy for AD. We now propose a clinical trial to evaluate the safety, feasibility, and biological effects of this strategy. The study will enroll 30 individuals with AD, ages 50 to 86, who have a confirmed diagnosis by amyloid PET brain imaging and a Mini-Mental State Exam score between 16 and 26. Participants will be randomly assigned to one of three groups: (1) placebo, (2) low-dose IL-2 alone, or (3) IL-2 combined with semaglutide. Throughout the trial, participants will undergo regular medical exams, blood tests, and safety monitoring. We will measure how the treatment affects Tregs and other immune cells, inflammatory markers in blood and CSF, and established Alzheimer's biomarkers such as amyloid beta, tau, and neurofilament light chain. Cognitive and functional assessments will also be conducted to explore potential ben
Interventions
- DRUG Placebo
- DRUG IL-2 (Aldesleukin)
- DRUG Semaglutide Plus IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07651319
The ClinicalTrials.gov registry entry for NCT07651319 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 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 3 interventions - of which Placebo is the first listed.
NCT07651319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07651319 about?
NCT07651319 is a clinical study titled "Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease". Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited. Growing evidence suggests that inflammation in the brain and the body plays a key role in the onset and progression of AD. In part...
What is the current status of trial NCT07651319?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-07. Estimated completion is 2029-12.
What interventions are being tested in trial NCT07651319?
The interventions under investigation include: Placebo (DRUG), IL-2 (Aldesleukin) (DRUG), Semaglutide Plus IL-2 (DRUG).
Who is sponsoring clinical trial NCT07651319?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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