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Alzheimer DiseasePhase 2IL-2-ADNCT05468073

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

A Phase 2 study testing Proleukin in people with Alzheimer Disease, run by Centre Hospitalier St Anne at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Proleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteFrance
Study dates
11 Oct 2022to 8 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • GHU Saint Anne

    Paris, 75674

Other trials in France

About this study

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.

Read the detailed description

This study aims to investigate the immunomodulatory therapeutic potential and safety of low-dose (ld) IL-2 in a randomized, double blind, and placebo-controlled phase II clinical trial.

Conservative diagnosis criteria based on clinical and CSF biomarkers have been established to avoid risks of misdiagnosis.

The treatment consist of 21 cures of subcutaneous injections of either placebo or low-dose (1MIU/day) IL-2 (PROLEUKIN ®). Patients will receive 5 consecutive injections during the induction phase which will be followed by a week break. During the maintenance phase a total of 16 injections will be administered weekly. Total duration of treatment for each patient is anticipated to be 18 weeks. Patients will be followed-up for 18 months after the first injection.

At inclusion, in addition to the clinical evaluation, a hybrid PET/MRI (using [18F]-DPA-714) scan will be performed. After randomized patients successfully complete the treatment phases, they will be followed-up through 3 clinical and 1 neuroimaging visits to assess cogitive and functional decline. Clinical visits are scheduled at 6, 12, and 18 months after treatment induction. Another hybrid PET/MRI (using [18F]-DPA-714) scan will be performed at 19 months following induction.

Being tested
Proleukin, Placebo
Keywords
Interleukin, Neuroinflammation, Regulatory T cells, Microglia, Synaptic density
Medical subject headings
Alzheimer Disease, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProleukinDrug

    Also called Interleukin 2

    Sub-cutaneous injections of Interleukin-2 (PROLEUKIN ®) Induction phase: 5 consecutive days. A week break. Maintenance phase: once a week during 16 weeks

  • PlaceboDrug

    Also called Sodium chloride solution

    Sub-cutaneous injections of placebo (NaCl) Induction phase: 5 consecutive days. A week break. Maintenance phase: once a week during 16 weeks.

Study groups in NCT05468073
Study groupRoleWhat they receive
TreatmentExperimentalPatient will be treated with low dose of Interleukin 2 (PROLEUKIN ®)
Receives: Drug: Proleukin
PlaceboPlacebo comparatorPatient will receive sodium chloride solution (NaCl)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline CDR score at 18 months

    The primary endpoint will be evaluated in all patients evaluable for efficacy, i.e. patients who received at least one cure of IL-2 and were evaluated for cognitive and functional status at baseline and 18 months.

    The response variable will be dichotomized as follows:

    Responder patient = 1 (end of study CDR score <= baseline CDR score)

    Non-responder patient = 0 (end of study CDR score > baseline CDR score)

    Measured: 18 months

Secondary outcomes (9)

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

    MMSE total score out of 30

    Measured: 6, 12 and 18 months

  2. 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

    ADAS-Cog total score out of 85

    Measured: 6, 12 and 18 months

  3. 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

    ADSC-ADL MCI total score out of 53

    Measured: 6, 12 and 18 months

  4. 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

    CDR sum of the boxes (CDR-SOB) total score out of 18

    Measured: 6, 12 and 18 months

  5. 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

    Global and regional cortical [18F]-DPA-714 PET uptake ratio

    Measured: 18 months

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

    Tregs frequency, total lymphocytes as a biomarker of target engagement

    Measured: 6, 12 and 18 month

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

    Volume of hippocampus measured in T1 MRI

    Measured: 18 months

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

    Clinical safety will be assessed via the following assessments:

    Vital signs (including blood pressure, weight, BPM, temperature) - each visit

    ECG - at inclusion and at V22 (M18)

    Check-list questionnaire to assess clinical adverse events - each visit

    Measured: 18 months

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

    Biological safety will be evaluated and controlled through blood laboratory safety tests which include the following:

    Thyroid function: T4 and TSH - at inclusion, at V21

    Haematology (RBC, WBC, leukocyte formula, platelets) and C reactive protein (CRP) - at inclusion, 8 days before the randomization, each day of the induction phase (day 1 to day 5), before each injection of the maintenance phase until V7, then every fortnight until the last injection of the maintenance phase, and then at M6, M12 and M18.

    Biochemistry (electrolytes, proteins, albumin, urea, creatinine, glucose, AST, ALT, GGT, bilirubin) and Coagulation tests - at inclusion, 8 days before the randomization, every 2 months for 6 months (V9 and V17), and at M6, M12 and M18

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start11 Oct 2022
  3. Primary completion8 Jun 2028 (estimated)
  4. Study completion8 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05468073
Sponsor's protocol ID
D20-P012
Acronym
IL-2-AD
Status last verified
Jun 2026
First submitted
21 Dec 2020
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proleukin in people with Alzheimer Disease, run by Centre Hospitalier St Anne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline CDR score at 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05468073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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