Informations générales (source: ClinicalTrials.gov)
Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD (IL-2-AD)
Interventional
Phase 2
Centre Hospitalier St Anne (Voir sur ClinicalTrials)
octobre 2022
septembre 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | Viviane AWASSI | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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