Alzheimer Disease
Conditions
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.
Interventions
DRUGAldesleukin
Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 86 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed