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Low Dose IL2 Immunotherapy in AD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05821153
Recruitment Status : Completed
First Posted : April 20, 2023
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Alireza Faridar, The Methodist Hospital Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Aldesleukin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : April 27, 2022
Actual Study Completion Date : April 27, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aldesleukin

Arms and Interventions
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Intervention Details:
  • Drug: Aldesleukin
    Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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



Eligibility Criteria
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Ages Eligible for Study:   60 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05821153


Locations
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United States, Texas
Alireza Faridar
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital Research Institute
Investigators
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Principal Investigator: Alireza Faridar Houston Methodist Neurological Institute
More Information
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Responsible Party: Alireza Faridar, Assistant Professor, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT05821153    
Other Study ID Numbers: PRO00021747
First Posted: April 20, 2023    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents