RecruitingPhase 2NCT05468073

Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

Sponsor

Centre Hospitalier St Anne

Enrollment

45 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

Study aims at evaluating the therapeutic efficacy and safety of low-dose IL-2 immunomodulatory treatment in patients with early AD, in a phase II, randomized, double blind, placebo-controlled phase II clinical trial. Patients with AD at early stage will be recruited and randomized (2:1) in each treatment group. The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating low-dose interleukin-2 (IL-2), an immune-modulating treatment, for people with autoimmune conditions or immune-related disorders. IL-2 at low doses can help "calm down" an overactive immune system. **You may be eligible if...** - You have been diagnosed with an autoimmune disease or inflammatory condition being studied in this trial - You are an adult who meets the specific health criteria for your condition - You are willing to attend regular follow-up visits **You may NOT be eligible if...** - You have serious infections or immune deficiency - You have severe heart, liver, or kidney disease - You are pregnant or breastfeeding - You are already on immunosuppressive medications that may interfere with the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGProleukin

Sub-cutaneous injections of Interleukin-2 (PROLEUKIN ®) Induction phase: 5 consecutive days. A week break. Maintenance phase: once a week during 16 weeks

DRUGPlacebo

Sub-cutaneous injections of placebo (NaCl) Induction phase: 5 consecutive days. A week break. Maintenance phase: once a week during 16 weeks.

Locations(1)

GHU Saint Anne

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05468073

Related Trials

A Study of LY3439539 in Participants With Alzheimer's Disease

NCT075983707 locations

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

NCT06937229255 locations