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IL-2-AD

RecruitingPhase 2

Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

Lead sponsor

Centre Hospitalier St Anne

Asset

Aldesleukin

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Change from baseline CDR score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD20-P012

NCT IDNCT05468073

Timeline

Milestones

Study first posted2022-07-21actual

Study start2022-10-11actual

Last update posted2024-06-12actual

Primary completion2025-09-01estimated

Study completion2026-09-01estimated

Assets

Drug assets

Aldesleukin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Safety / tolerability / PK

Function / daily living

Neuroimaging

Global cognition

3 endpoints

Secondary/protocol endpoint

Rate of cognitive decline between placebo and treatment groups as assessed by changes in MMSE scores at baseline, 6, 12, and 18 months

Time frame:6, 12 and 18 months

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Rate of cognitive decline between placebo and treatment groups as assessed by changes in ADAS-Cog 13 items scores at baseline, 6, 12, and 18 months

Time frame:6, 12 and 18 months

ADAS-Cog

descriptive

Secondary/protocol endpoint

Rate of functional decline between placebo and treatment groups as assessed by changes in CDR (sum of boxes) scores at baseline, 6, 12, and 18 months

Time frame:6, 12 and 18 months

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Rate of functional decline between placebo and treatment groups as assessed by changes in ADCS-ADL MCI scores at baseline, 6, 12, and 18 months

Time frame:6, 12 and 18 months

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Change in hippocampal atrophy at 18 month compared to baseline between placebo and treated groups

Time frame:18 months

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of patients with treatment related adverse events as assessed by clinical safety panel

Time frame:18 months

event count, event

Secondary/protocol endpoint

Number of patients with treatment related adverse events as assessed by blood laboratory safety panel

Time frame:18 months

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Change from baseline CDR score at 18 months

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in neuroimmune reaction as assessed by [18F]-DPA-714 PET global cortical index and regional cortical binding at baseline and 18 months between placebo and treated groups

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in peripheral frequency of Treg and other immune effectors at 18 months compared to baseline between placebo and treated groups

Time frame:6, 12 and 18 month

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.