Phase II Clinical Trial of Interleukin-2 in AD
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ClinicalTrials.gov Identifier: NCT06096090 |
Recruitment Status :
Recruiting
First Posted : October 23, 2023
Last Update Posted : December 7, 2023
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Sponsor:
The Methodist Hospital Research Institute
Information provided by (Responsible Party):
Alireza Faridar, The Methodist Hospital Research Institute
Tracking Information | |||||||
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First Submitted Date ICMJE | October 17, 2023 | ||||||
First Posted Date ICMJE | October 23, 2023 | ||||||
Last Update Posted Date | December 7, 2023 | ||||||
Actual Study Start Date ICMJE | March 17, 2023 | ||||||
Estimated Primary Completion Date | December 30, 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
To assess the safety and the tolerability of IL-2 in AD patients [ Time Frame: 6 months treatment phase ] Primary endpoint:
- Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
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Current Secondary Outcome Measures ICMJE |
To investigate the impact of IL-2 administration on the blood Treg population in AD patients [ Time Frame: 6 months treatment phase ] Secondary Endpoint:
- Change in Treg percentage out of total CD4 cells
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase II Clinical Trial of Interleukin-2 in AD | ||||||
Official Title ICMJE | A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients With Mild to Moderate Alzheimer's Disease | ||||||
Brief Summary | Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer Disease | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 30, 2025 | ||||||
Estimated Primary Completion Date | December 30, 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 86 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT06096090 | ||||||
Other Study ID Numbers ICMJE | PRO00030798 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Alireza Faridar, The Methodist Hospital Research Institute | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | The Methodist Hospital Research Institute | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | The Methodist Hospital Research Institute | ||||||
Verification Date | December 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |