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CompletedPhase 1

Low Dose IL2 Immunotherapy in AD

Phase I Trial Using Interleukin-2 (IL-2) to Expand Regulatory T Cells in Patients With Alzheimer's Disease

Asset

Aldesleukin

Listed sites

1

Recruiting sites

-

Enrollment

8

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Safety and the tolerability of IL-2 in AD patients

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

NCT IDNCT05821153
Org study IDPRO00021747

Timeline

Milestones

Study start2019-06-19actual
Primary completion2022-04-27actual
Study completion2022-04-27actual
Study first posted2023-04-20actual
Last update posted2023-04-20actual

Assets

Drug assets

Aldesleukin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
Maximum age86 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.
•Male or female age 60 to 86 years
•Clinical dementia rating scale of 1
•Total bilirubin less than or equal to 1.5mg/dL
•Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0gm/dL
•Serum creatinine less than 1.5 mg/dL
•English language speaking
•A family member or caretaker who is expected to be consistently available, administer study drug and attend study visits throughout the study

Exclusion criteria

•Serious, active bacterial, fungal or viral infection
•Severe pulmonary dysfunction. FEV1 and FVC less than 40% of predicted (or 3 SD below normal) at baseline, If a pulmonary function test is clinically indicated. Hx of intubation for >72 hours.
•Severe cardiac dysfunction defined as left ventricular ejection fraction <40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
•Hypersensitivity or allergy to IL-2
•Bowel ischemia/perforation, GI bleeding requiring surgery
•Resistant seizures, history of coma or toxic psychosis lasting >48 hours
•Patients with White Blood Count (WBC) <4,000/mm3; platelets <100,000/mm3; hematocrit (HCT) <30%.

Endpoints (2)

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

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To assess the safety and the tolerability of IL-2 in AD patients

Time frame:4 months treatment phase

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

To investigate the impact of low dose IL-2 administration on the blood Treg population in AD patients.

Time frame:4 months treatment phase

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.