30 Participants NeededMy employer runs this trial

IL-2 + Semaglutide for Alzheimer's Dementia

AA
Overseen ByAlireza Alireza, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: The Methodist Hospital Research Institute
Must be taking: Stable AD meds

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for Alzheimer's disease, examining how interleukin-2 (a drug that helps control inflammation) and semaglutide (a drug that reduces inflammation and protects brain cells) work together to slow the disease's progression. Participants will join one of three groups: a placebo group, a group receiving only interleukin-2, or a group receiving both interleukin-2 and semaglutide. Those with a confirmed Alzheimer's diagnosis who can still manage daily activities with some help might be suitable for the trial. Researchers will monitor the treatments' effects on inflammation, brain health, and daily functioning. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Interleukin-2 (IL-2) is generally safe for patients with Alzheimer's disease. One study using a low dose of IL-2 found encouraging results. Patients tolerated the treatment well, experiencing no severe side effects. The study also noted improvements in cognitive abilities and important health markers related to Alzheimer's.

Semaglutide, already approved for treating diabetes and obesity, has a strong safety record. In Alzheimer's research, semaglutide was associated with a 40-70% lower risk of an Alzheimer's diagnosis compared to some other drugs. This is promising because it helps reduce inflammation and protect brain cells.

In summary, both IL-2 and semaglutide have been well tolerated in studies, with no major safety concerns reported. This makes them promising options for further testing in Alzheimer's treatment.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Interleukin-2 (IL-2) and Semaglutide for Alzheimer's because it offers a novel approach by targeting both the immune and metabolic systems. Most treatments for Alzheimer's focus on reducing amyloid plaques or tau tangles in the brain. However, IL-2 is unique as it aims to modulate the immune system, potentially reducing inflammation that could contribute to Alzheimer's progression. Meanwhile, Semaglutide, commonly used for diabetes, could improve brain health by enhancing glucose metabolism. This dual-action strategy could provide a fresh avenue for tackling Alzheimer's beyond the traditional methods.

What evidence suggests that this trial's treatments could be effective for Alzheimer's?

Research has shown that Interleukin-2 (IL-2) can help manage inflammation in Alzheimer's disease by improving the function of certain cells that control harmful immune responses. Some studies suggest that low doses of IL-2 might enhance memory and thinking skills, offering potential benefits for Alzheimer's. In this trial, participants may receive low-dose IL-2 monotherapy.

Semaglutide, a drug often used for diabetes, has been linked to a lower risk of developing Alzheimer's. It reduces inflammation and protects brain cells. Participants in this trial may also receive a combination of IL-2 and semaglutide, which research suggests works better together than alone. This combination aims to reduce brain inflammation and protect brain cells, potentially slowing the progression of Alzheimer's.35678

Are You a Good Fit for This Trial?

This trial is for people aged 50-86 with a confirmed diagnosis of Alzheimer's disease, mild to moderate memory loss (MMSE score 16-26), stable on current medications, able to attend visits with a caregiver, and generally in good health. People with serious heart, lung, liver or kidney problems, recent cancer, certain infections or allergies to study drugs cannot join.

Inclusion Criteria

I have been on a stable dose of my memory medication for at least 4 weeks.
MMSE between 16-26
Albumin greater than or equal to 3.0mg/dL
See 9 more

Exclusion Criteria

I do not have severe or unstable health problems that could affect the study results.
Any condition making patient unsuitable for inclusion in opinion of investigator
Suspected or known drug or alcohol abuse indicated by elevated MCV significantly above normal at screening
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo, low-dose IL-2 alone, or IL-2 combined with semaglutide. IL-2 is administered subcutaneously once daily for 5 consecutive days, repeated every 4 weeks for six cycles. Semaglutide is administered with stepwise dose escalation once weekly.

6 months
Regular medical exams, blood tests, and safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive and functional benefits.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Interleukin-2 (IL-2)
  • Semaglutide

Trial Overview

The study tests if combining low-dose IL-2 (a drug that affects the immune system) and semaglutide (used for diabetes/obesity) can safely help people with Alzheimer's. Participants are randomly assigned to receive either placebo, IL-2 alone, or both IL-2 plus semaglutide. The effects on brain inflammation and memory will be monitored.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Low-dose recombinant human IL-2 (LD IL-2) monotherapyActive Control1 Intervention
Group II: IL-2 Plus Semaglutide combination therapyActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Citations

expert reaction to two new studies on diabetes drugs ...

“Tang found overall no difference between the risk of Alzheimer disease and related dementias between type 2 diabetes patients taking GLP-1RAs ...

J Prev Alz Dis 2026;2(13)

... DISORDER AND ALZHEIMER'S DISEASE DEMENTIA: RESULTS FROM A PHASE 2 RANDOMIZED CLINICAL TRIAL, J Prev Alz Dis 2021;1(8):7-18, 3668. EDITORIAL: HARNESSING ...

Semaglutide Biomarkers and Alzheimer's Research (2026)

Several ongoing clinical trials are evaluating semaglutide's safety and efficacy in patients with mild cognitive impairment or early Alzheimer's disease.

An emulated clinical trial observational study

Semaglutide had the highest unweighted event rate of AD/ADRD. Liraglutide had a lower risk of AD/ADRD compared to semaglutide as well as a ...

Novo Nordisk today announced the ...

Across both two trials, the mean age was 72 and 52.5 Semaglutide fails to slow cognitive decline in early Alzheimer's Medscape 40w

Alzheimer's Association Statement on Oral Semaglutide ...

Semaglutide significantly reduces risk of major kidney disease events, cardiovascular outcomes and mortality in patients with type 2 diabetes ...

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

It measures safety, immune cells, inflammation and Alzheimer's blood and spinal fluid markers. It is a Phase 1 trial, an early test of safety, ...

More Evidence Ties Semaglutide to Reduced Alzheimer's ...

Compared with the other medications, semaglutide was associated with a 40%-70% reduced risk for first-time diagnosis of Alzheimer's disease in ...