Clinical trial NCT05821153: Low Dose IL2 Immunotherapy in AD
Official title: Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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%.

Primary outcomes:
measure: To assess the safety and the tolerability of IL-2 in AD patients
timeFrame: 4 months treatment phase
Secondary outcomes:
measure: To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.
timeFrame: 4 months treatment phase
Other outcomes:
Locations:
city: Houston
country: United States
facility: Alireza Faridar
state: Texas
Study officials:
affiliation: Houston Methodist Neurological Institute
name: Alireza Faridar
role: PRINCIPAL_INVESTIGATOR
References: