Alzheimer Dementia study: IL-2 vs Semaglutide Plus IL-2
Official title Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease
ClinicalTrials.gov ID: NCT07651319
What this study is testing
What is Aldesleukin?
an investigational subcutaneous injectable medicine being studied as a potential treatment for Alzheimer’s disease (AD) is designed to boost regulatory T‑cell function and reduce inflammation
Also referred to as IL-2.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if the drug combo is safe and how it affects immune cells and Alzheimer’s biomarkers.
- Who it's for
- People aged 50‑86 with confirmed Alzheimer’s disease and a Mini‑Mental State Exam score of 16‑26.
- What's involved
- Participants will be randomly assigned to placebo, low‑dose IL‑2 alone, or IL‑2 plus semaglutide, and will have regular medical exams, blood draws, safety checks, and cognitive tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 86
You may be able to join if
- 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%.
You likely can't join if
- 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])...
- Clinically significant cardiac dysfunction, including a history of uncontrolled cardiac arrhythmias, prior cardiac tamponade, or unstable angina or...
- Hypersensitivity or allergy to IL-2
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)
- Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)
- Seizure disorder
- History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)
- Clinically significant abnormal T4 or TSH
- Respiratory insufficiency
- Bradycardia (\ 100/min.)
- 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)
- 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...
- 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
- Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 86 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.