Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD (NCT05468073) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD
France40 participantsStarted 2022-10-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.