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Phase 1
Phase 2
Age: 50Years - 86Years
All Genders
ID07651319

Evaluating Safety and Immune Effects of IL-2 and Semaglutide Combination Therapy in Adults Aged 50 to 86 with Alzheimers Disease

Led by The Methodist Hospital Research Institute · Updated on 2026-06-16

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Alzheimers disease AD is the most common cause of dementia, and current treatments to slow or stop its progression are limited. Research shows that inflammation and impaired regulatory T cells Tregs contribute to AD progression. This trial evaluates a combination therapy using Interleukin-2 IL-2, which restores Treg function, and semaglutide, a drug that reduces inflammation and protects brain cells. The study aims to assess the safety, feasibility, and biological effects of this combined treatment in adults with AD. Participants aged 50 to 86 with confirmed AD diagnosis and specific cognitive scores will be randomly assigned to one of three groups placebo, low-dose IL-2 alone, or IL-2 combined with semaglutide. IL-2 is given as a subcutaneous injection daily for 5 days every 4 weeks over six cycles, while semaglutide is administered once weekly with dose escalation. The trial lasts 6 months and compares the effects of these treatments on immune function and AD biomarkers. Throughout the study, participants will have regular medical exams, blood tests, and safety monitoring. Researchers will measure changes in immune cells, inflammatory markers in blood and cerebrospinal fluid, and key AD indicators such as amyloid beta and tau proteins. Cognitive and daily function tests will explore possible benefits on memory and living skills. The total participation duration includes treatment and follow-up for safety and biological effects.

CONDITIONS

Brief Title

Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease

Research Team

A

Alireza Alireza, MD

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