Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05821153
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2023-03-27
Brief Title:
Low Dose IL2 Immunotherapy in AD
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase I Trial Using Interleukin-2 IL-2 to Expand Regulatory T Cells in Patients With Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1MUIday 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None