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Immunomodulator

IL-2 + Abatacept for Frontotemporal Dementia

Phase 1
Recruiting
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of probable frontotemporal dementia
Be older than 18 years old
Must not have
History of severe pulmonary dysfunction
History of severe cardiac dysfunction defined as left ventricular ejection fraction <40%; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months treatment phase
Awards & highlights

Summary

This trial aims to study the use of low dose interleukin-2 (IL-2) and abatacept in treating Frontotemporal Disorder (FTD) by targeting neuroinflamm

Who is the study for?
This trial is for individuals with Frontotemporal Dementia (FTD). Participants should have a compromised immune system, specifically with regulatory T cells that are not functioning properly. The study aims to recruit FTD patients who can undergo treatment with immunotherapy drugs.
What is being tested?
The trial is testing the combination of two drugs: Abatacept and Aldesleukin (IL-2), which may help regulate the immune system in FTD. It's an open-label phase I study, starting with five patients receiving these drugs over 21 weeks to check safety and tolerability before possibly expanding to more participants.
What are the potential side effects?
Potential side effects aren't specified here but could include reactions at injection sites, changes in blood counts or immune function due to Abatacept and IL-2's action on the body's regulatory T cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with frontotemporal dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious lung problems.
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I do not have severe heart problems like recent heart attacks or uncontrolled irregular heartbeats.
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I have a seizure disorder.
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I have had issues with my bowels like blockages, tears, or serious bleeding needing surgery.
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I don't have any health conditions that could affect the study's results.
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I do not have any serious infections or tuberculosis.
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I haven't been hospitalized or changed my long-term medication in the last month.
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I have not had significant brain injuries or conditions like large bleeds, strokes, or tumors.
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I have been diagnosed with a form of dementia such as Alzheimer's or Parkinson's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months treatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months treatment phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the safety and the tolerability of abatacept plus IL-2 in FTD patients
Secondary study objectives
To investigate the impact of low dose IL-2 plus abatacept administration on the blood Treg population in FTD patients

Trial Design

2Treatment groups
Active Control
Group I: Abatacept plus Aldesleukin every 4 weeksActive Control1 Intervention
Subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every four weeks will be administered for a total of 21 weeks
Group II: Abatacept plus Aldesleukin every 2 weeksActive Control1 Intervention
Subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every two weeks will be administered for a total of 21 weeks

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Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
281 Previous Clinical Trials
81,596 Total Patients Enrolled
~7 spots leftby Apr 2026
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