Low Dose IL2 Immunotherapy in AD

• ClinicalTrials.gov Identifier: NCT05821153
• Recruitment Status: Completed
• First Posted: April 20, 2023
• Last Update Posted: April 20, 2023
• Sponsor: The Methodist Hospital Research Institute
• Information provided by (Responsible Party): Alireza Faridar, The Methodist Hospital Research Institute

Tracking Information

• First Submitted Date: March 27, 2023
• First Posted Date: April 20, 2023
• Last Update Posted Date: April 20, 2023
• Actual Study Start Date: June 19, 2019
• Actual Primary Completion Date: April 27, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2023)

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 19, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alzheimer Disease

Intervention

Drug: Aldesleukin

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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2023): 8
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 27, 2022
• Actual Primary Completion Date: April 27, 2022 (Final data collection date for primary outcome measure)

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%.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 86 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05821153
• Other Study ID Numbers: PRO00021747
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Alireza Faridar, The Methodist Hospital Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: The Methodist Hospital Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alireza Faridar; Houston Methodist Neurological Institute

• PRS Account: The Methodist Hospital Research Institute
• Verification Date: March 2023