Low Dose IL2 Immunotherapy in AD
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- To assess the safety and the tolerability of IL-2 in AD patients [4 months treatment phase]
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. [4 months treatment phase]
Secondary endpoints: - Change in Treg percentage out of total # of CD4 cells from baseline to month 4
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.
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Male or female age 60 to 86 years
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Clinical dementia rating scale of 1
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Total bilirubin less than or equal to 1.5mg/dL
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Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0gm/dL
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Serum creatinine less than 1.5 mg/dL
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English language speaking
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A family member or caretaker who is expected to be consistently available, administer study drug and attend study visits throughout the study.
Exclusion Criteria:
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Serious, active bacterial, fungal or viral infection
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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.
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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
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Hypersensitivity or allergy to IL-2
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Bowel ischemia/perforation, GI bleeding requiring surgery
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Resistant seizures, history of coma or toxic psychosis lasting >48 hours
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Patients with White Blood Count (WBC) <4,000/mm3; platelets <100,000/mm3; hematocrit (HCT) <30%.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alireza Faridar | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The Methodist Hospital Research Institute
Investigators
- Principal Investigator: Alireza Faridar, Houston Methodist Neurological Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO00021747