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Could a diabetes drug and immune therapy slow Alzheimer's? new trial launches

NCT ID NCT07651319

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether combining interleukin-2 (IL-2) with semaglutide (a diabetes drug) can safely reduce harmful inflammation in the brains of people with Alzheimer's disease. The study will enroll 30 adults aged 50–86 with mild-to-moderate Alzheimer's. Participants will receive either placebo, IL-2 alone, or IL-2 plus semaglutide for six months. Researchers will monitor safety, immune cell changes, and markers of brain health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Interleukin-2 (IL-2) and semaglutide
What this could lead to
If successful, this could point toward a new treatment that slows Alzheimer's progression by calming brain inflammation.
What could go wrong
This is an early, small trial (30 people) focused on safety. The combination may not show clear benefits, and side effects from the drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 86 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13. * Male or female age 50 to 86 years * MMSE between 16-26 * Albumin greater than or equal to 3.0mg/dL * White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%. * INR\<1.4 * If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study. * English language speaking * Formal education of eight or more years * Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening * A family member or caretaker who is expected to be consistently available, administer study drugs of IL-2 and attend study visits throughout the study. * For AD patients with limited decision-making capacity, the legally authorized representative (LAR) should be present and consent based on the patient's best interest. Exclusion Criteria: * Any untreated bacterial, fungal or viral infection * Renal dysfunction indicated by serum creatinine greater than 1.5 mg/dL * Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal * Clinically significant pulmonary dysfunction, including a history of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\]) associated with functional limitation, or FEV₁ \< 75% of predicted for age and height when pulmonary function testing indicated to evaluate ongoing respiratory symptoms * Clinically significant cardiac dysfunction, including a history of uncontrolled cardiac arrhythmias, prior cardiac tamponade, or unstable angina or myocardial infarction within 3 months prior to screening, or clinically significant abnormalities on baseline electrocardiogram (ECG). LVEF\< 40% in echocardiography if clinically indicated based on ongoing cardiac symptoms or abnormal ECG findings * Hypersensitivity or allergy to IL-2 * History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening. * History of hemorrhage or infarct or \> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI. * Clinical or laboratory findings consistent with: 1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.) 2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.) 3. Seizure disorder 4. History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.) 5. Clinically significant abnormal T4 or TSH * Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as: 1. Respiratory insufficiency 2. Bradycardia (\<45/min.) or tachycardia (\>100/min.) 3. Poorly managed hypertension (systolic \>160 mm Hg and/or diastolic \>95 mm Hg) or hypotension (systolic \<90 mm Hg and/or diastolic \<60 mm Hg) 4. Uncontrolled diabetes defined by HbA1c \>8% * History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months. * History of acute/chronic hepatitis B or C and/or carriers of hepatitis B * History of organ allografts * Current treatment with insulin or insulin secretagogues (including sulfonylureas or meglitinides) * Prior GLP-1 RA administration or natural GLP1 supplements intake within the past 6 months * Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty, etc.). * Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg/day, quetiapine ≤100 mg/day, olanzapine ≤5 mg/day, and aripiprazole ≤10 mg/day), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests. * Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine. * Use of concomitant CYP-metabolized medications with a narrow therapeutic index including warfarin, calcineurin inhibitors, or theophylline) * Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening * Suspected or known allergy to any components of the study treatments. * Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer. * Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR \>1.4 or other coagulopathy; platelet count of \<100,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma. * Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.