Actively Recruiting

Phase 2
Age: 50Years - 86Years
All Genders
NCT06096090

Phase II Clinical Trial of Interleukin-2 in AD

Led by The Methodist Hospital Research Institute · Updated on 2024-05-23

40

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks.

CONDITIONS

Official Title

Phase II Clinical Trial of Interleukin-2 in AD

Who Can Participate

Age: 50Years - 86Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
  • Male or female age 50 to 86 years
  • MMSE between 12-26
  • Total bilirubin less than or equal to 1.5mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal
  • Albumin greater than or equal to 3.0mg/dL
  • Serum creatinine less than or equal to 1.5 mg/dL
  • White Blood Count (WBC) greater than 3,500/mm3; platelets greater than 100,000/mm3; hematocrit (HCT) greater than 32%
  • International Normalized Ratio (INR) less than 1.4
  • Stable dosage of medications affecting cognition for at least 4 weeks prior to screening and during study
  • English speaking
  • Formal education of eight or more years
  • Stable treatment of other chronic conditions for at least 30 days prior to screening
Not Eligible

You will not qualify if you...

  • Serious, active bacterial, fungal or viral infection, active or latent tuberculosis
  • History of severe pulmonary dysfunction
  • Severe cardiac dysfunction including low ejection fraction, uncontrolled arrhythmias, tamponade, unstable angina, or recent heart attack
  • Allergy or hypersensitivity to IL-2
  • History of bowel ischemia, perforation, or gastrointestinal bleeding requiring surgery
  • Hospitalization or medication changes within one month prior to screening
  • History of significant brain injuries or abnormalities seen on CT or MRI
  • Other primary degenerative dementias or neurodegenerative conditions
  • Seizure disorders
  • Infectious, metabolic, or systemic diseases affecting the central nervous system
  • Abnormal thyroid function tests
  • Active major depression, schizophrenia, or bipolar disorder (managed depression allowed)
  • Serious or unstable diseases interfering with evaluations such as respiratory insufficiency, abnormal heart rates, poorly managed blood pressure, or uncontrolled diabetes
  • Recent history of cancer with exceptions
  • Hepatitis B or C infection or carrier status
  • Disability preventing study completion
  • Use of certain psychotropic or other excluded medications
  • Use of nootropic drugs except stable AD meds
  • Drug or alcohol abuse
  • Allergy to study treatment components
  • Recent use of investigational drugs or AD immunotherapies
  • Chronic steroid or interferon therapy
  • Contraindications to lumbar puncture
  • Any condition making the patient unsuitable for inclusion in the investigator's opinion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Houston Methodist Research Institute

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Alireza Faridar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Phase II Clinical Trial of Interleukin-2 in AD | DecenTrialz