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OpenTrials
Completed

NCT Number: NCT05821153

Low Dose IL2 Immunotherapy in AD

Neuroinflammation is a significant component of Alzheimer disease (AD). Our data demonstrated compromised regulatory T cells (Tregs) phenotype and suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing in disease progression. Low dose interleukin-2 (IL-2) is now viewed as a very promising immunoregulatory drug having the capacity to selectively expand and restore functional Tregs. This study is a phase I open-label study to assess subcutaneous interleukin-2 (IL2) safety and potential efficacy as a Treg inducer in AD. 8 Alzheimer dementia patients with mild clinical dementia will be recruited into the study. The baseline cognitive status will be evaluated in these patients. Monthly five-day-courses of subcutaneous IL2 (1MUI/day) will be administered for a total of 4 months. Changes in Tregs from pre to post injections will be measured during the study period. The expected time participants will be in the study is 6 months.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alireza Faridar

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.
  • Male or female age 60 to 86 years
  • Clinical dementia rating scale of 1
  • Total bilirubin less than or equal to 1.5mg/dL
  • Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0gm/dL
  • Serum creatinine less than 1.5 mg/dL
  • English language speaking
  • A family member or caretaker who is expected to be consistently available, administer study drug and attend study visits throughout the study.

Exclusion criteria

  • Serious, active bacterial, fungal or viral infection
  • Severe pulmonary dysfunction. FEV1 and FVC less than 40% of predicted (or 3 SD below normal) at baseline, If a pulmonary function test is clinically indicated. Hx of intubation for >72 hours.
  • Severe cardiac dysfunction defined as left ventricular ejection fraction <40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
  • Hypersensitivity or allergy to IL-2
  • Bowel ischemia/perforation, GI bleeding requiring surgery
  • Resistant seizures, history of coma or toxic psychosis lasting >48 hours
  • Patients with White Blood Count (WBC) <4,000/mm3; platelets <100,000/mm3; hematocrit (HCT) <30%.

Treatment and study plan

Aldesleukin

Drug

Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

Primary outcomes

  1. To assess the safety and the tolerability of IL-2 in AD patients

    Time frame: 4 months treatment phase

    Primary endpoints:

    • Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).

Secondary outcomes

  1. To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.

    Time frame: 4 months treatment phase

    Secondary endpoints:

    • Change in Treg percentage out of total # of CD4 cells from baseline to month 4

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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