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

NCT05468073 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-06-12

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Proleukin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • For Drug Consulting

    collaborator OTHER

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Marie SARAZIN, Prof · GHU Saint Anne

  • Guillaume DOROTHEE, PhD · INSERM UMRS 938

  • Michel BOTTLAENDER, Dr · Service Hospitalier Frédéric Joliot / CEA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2025-09-01
Completion
2026-09-01

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468073 on ClinicalTrials.gov