Can a Low-Dose immune calmer slow Alzheimer's decline?
NCT ID NCT05468073
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether low-dose interleukin-2 (IL-2), an immune-modulating drug, can slow cognitive decline in people with early Alzheimer's disease. Forty participants will receive either IL-2 injections or a placebo for several months, and their cognitive function will be tracked over 18 months. The goal is to see if calming certain immune cells can protect the brain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose interleukin-2 (IL-2), given as subcutaneous injections
- What this could lead to
- If it works, this could point toward a new way to slow memory loss and functional decline in early Alzheimer's by calming the immune system.
- What could go wrong
- This is a small, early-phase trial. The immune approach is experimental, and it is unknown whether it will meaningfully slow cognitive decline or cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Oct 2022
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
GHU Saint Anne
Paris, 75674, France
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