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Low Dose IL2 Immunotherapy in AD

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Alireza Faridar

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2023
Last Updated
April 19, 2023
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05821153
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aldesleukin
Intervention Description
Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells
Primary Outcome Measure Information:
Title
To assess the safety and the tolerability of IL-2 in AD patients
Description
Primary endpoints: - Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).
Time Frame
4 months treatment phase
Secondary Outcome Measure Information:
Title
To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.
Description
Secondary endpoints: - Change in Treg percentage out of total # of CD4 cells from baseline to month 4
Time Frame
4 months treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Faridar
Organizational Affiliation
Houston Methodist Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alireza Faridar
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Low Dose IL2 Immunotherapy in AD

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