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Therapeutic evaluation of low-dose IL-2-based immunomodulatory approach in patients with early Alzeihmer Disease
EU CTIS ID: 2024-516565-36-00
What this study is testing
The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged > 18
- Clinical and biological diagnosis of AD based on o Progressive amnestic syndrome associated or not with other cognitive impairments o 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.
- The subject lives with (or has regular periods of contact with) a permanent caregiver who is ready to attend the inclusion and the clinical follow-up visits (V1, V20, V21, V22), is ready to attend or to be contacted for each treatment visit (V3 to V19), supervises the subject’s compliance with the procedures specified in the protocol, and reports on subject’s condition.
You likely can't join if
- Subject with a psychiatric evolutionary and/or badly checked
- History within the past 5 years of a primary or recurrent malignant disease (with the exception of fully excised non-melanoma skin cancers).
- 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
See the full eligibility criteria
Who can join
- Patients aged > 18
- Clinical and biological diagnosis of AD based on o Progressive amnestic syndrome associated or not with other cognitive impairments o 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.
- The subject lives with (or has regular periods of contact with) a permanent caregiver who is ready to attend the inclusion and the clinical follow-up visits (V1, V20, V21, V22), is ready to attend or to be contacted for each treatment visit (V3 to V19), supervises the subject’s compliance with the procedures specified in the protocol, and reports on subject’s condition.
- 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.
What rules you out
- Subject with a psychiatric evolutionary and/or badly checked
- History within the past 5 years of a primary or recurrent malignant disease (with the exception of fully excised non-melanoma skin cancers).
- 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
- 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%
- 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.
- Patients with serum bilirubin and creatinine outside normal range
- Patients with organ allografts
- Patients who are likely to require corticosteroids
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.