Evaluating low-dose IL-2 treatment for early Alzheimer's disease
Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD
This study is testing if a low-dose treatment called IL-2 can help people with early Alzheimer's disease by slowing down their memory decline.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05468073 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of low-dose interleukin-2 (IL-2) as an immunomodulatory treatment for patients with early-stage Alzheimer's disease (AD). It is a phase II, randomized, double-blind, placebo-controlled trial where participants will receive either low-dose IL-2 or a placebo through subcutaneous injections over an 18-week period. The primary endpoint is the change in cognitive decline measured by the Clinical Dementia Rating scale over 18 months. Participants will undergo clinical evaluations and neuroimaging assessments to monitor treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a clinical and biological diagnosis of early Alzheimer's disease and a CDR score of 0.5 or 1.
Not a fit: Patients with advanced Alzheimer's disease or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could slow cognitive decline in patients with early Alzheimer's disease.
How similar studies have performed: While similar immunomodulatory approaches have been explored, this specific low-dose IL-2 treatment in early Alzheimer's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 1 month 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
Where this trial is running
Paris
- GHU Saint Anne — Paris, France (Recruiting)
Study contacts
- Principal investigator: Marie SARAZIN, Prof — GHU Saint Anne
- Study coordinator: Khaoussou SYLLA, Dr
- Email: k.sylla@ghu-paris.fr
- Phone: 01 45 65 76 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.