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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin | Drug | Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alireza Faridar | Houston Methodist Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alireza Faridar | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37968718 | Derived | Faridar A, Eid AM, Thome AD, Zhao W, Beers DR, Pascual MB, Nakawah MO, Roman GC, Davis CS, Grundman M, Masdeu JC, Appel SH. A phase 1 open-label pilot study of low-dose interleukine-2 immunotherapy in patients with Alzheimer's disease. Transl Neurodegener. 2023 Nov 16;12(1):54. doi: 10.1186/s40035-023-00387-5. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |