Can a Low-Dose immune calmer slow Alzheimer's decline?

NCT ID NCT05468073

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Alzheimer disease Neuroinflammatory Diseases

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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Other studies related to the condition(s) this trial covers.