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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier St Anne
• Collaborator: For Drug Consulting
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

• Patients aged > 18

• Age of disease onset < 70 years

• Clinical and biological diagnosis of AD based on

• Progressive amnestic syndrome associated or not with other cognitive impairments

• Biological criteria: CSF biomarkers suggestive of AD.

• Brain MRI congruent with the diagnosis, left to the appreciation of the investigator

• CDR (Clinical Dementia Rating Scale) = 0.5 or 1

• If patients have an antidepressant or acetylcholinesterase inhibitors treatment, patients must be treated with stable doses of treatment for at least 3 months before inclusion.

• Have a caregiver who provides a separate written informed consent to participate. If a caregiver/study informant cannot continue, one replacement is allowed.

• Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator.

• Have given written informed consent approved by the ethical review board (ERB) governing the site.

• The patient has to have a French social security number and be fluent and literate in French.

Exclusion Criteria:

• Subject with a psychiatric evolutionary and/or badly checked.

• Subject with a grave, severe or unstable pathology (left to the judgement of the investigator) the nature of which can interfere with the variables of evaluation.

• Epileptic subjects

• Subject under guardianship or curatorship

• Subject presenting contraindications to the MRI

• Known or supposed history (< or = 5 years) of severe alcoholism or misuse of drugs

• Vascular, inflammatory or expansive, visible lesion in the MRI, which can interfere on the criteria of diagnosis.

• No health insurance

• Women of childbearing potential: a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

• History of auto-immune disease

• History within the past 10 years of a primary or recurrent malignant disease

• Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders (FTD, LBD, VaD, HD, PD, PSP-CBD).

• Renal dysfunction at inclusion, clearance <30 mL/min

• Chronic hepatic diseases as indicated by liver function tests abnormalities

• Abnormal thyroid function

• Therapeutic trial within 1 year preceding the first study period, or participation in a trial with active or passive immunization against amyloid if patient was assigned to the active treatment arm.

• Clinically significant evidence of Active viral infection (CMV, EBV, HCV, HBV, TPHA-VDRL, HIV)

• Current or medical history of severe cardiopathy,

• - Severe dysfunction in a vital organ

• Patients with White Blood Count (WBC) < 4.000/mm3; platelets < 100.000/mm3; hematocrit (HCT) < 30%.

• Patients with serum bilirubin and creatinine outside normal range.

• Patients with organ allografts.

• Patients who are likely to require corticosteroids