Low Dose IL2 Immunotherapy in AD

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821153
• Other study ID #: PRO00021747
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2019
• Est. completion date: April 27, 2022

Study information

• Verified date: March 2023
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 86 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
United States	Alireza Faridar	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 months treatment phase
Secondary	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	4 months treatment phase