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CompletedNCT05821153Updated Apr 20, 2023

Low Dose IL2 Immunotherapy in AD

A Phase 1 interventional study of Aldesleukin in Alzheimer Disease, sponsored by The Methodist Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 60 Years to 86 Years. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by The Methodist Hospital Research Institute · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2022, 4 years 5 months ago, and no results have been posted to the registry.
  • Registered 3 years 9 months after the study started (first participant enrolled Jun 2019, registered Mar 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
60 Years to 86 Years
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 8 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

The Methodist Hospital Research Institute is the lead sponsor of 157 studies on the registry; 60 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 15 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Interventions

  • DrugAldesleukin

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

06

What researchers measure

Primary outcomes

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

    Primary endpoints: - Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).

    Time frame: 4 months treatment phase

Secondary outcomes

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

    Secondary endpoints: - Change in Treg percentage out of total # of CD4 cells from baseline to month 4

    Time frame: 4 months treatment phase

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Study locations

1 site
  • Alireza Faridar
    Houston, Texas 77030, United States
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05821153
Lead sponsor
The Methodist Hospital Research Institute
Responsible party
Alireza Faridar (Assistant Professor, The Methodist Hospital Research Institute) — Principal investigator
First posted
Apr 20, 2023
Start date
Jun 19, 2019
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022
Last update
Apr 20, 2023

Study contacts

Alireza Faridar
principal investigator · Houston Methodist Neurological Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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