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Alzheimer DiseasePhase 2NCT06096090

Phase II Clinical Trial of Interleukin-2 in AD

A Phase 2 study testing Interleukin-2 in people with Alzheimer Disease, run by The Methodist Hospital Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease… Read more about this study

Who is it for?
Ages 50 to 86 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Interleukin-2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 30 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 50 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
  • Male or female age 50 to 86 years
  • MMSE between 12-26
  • Total bilirubin less than or equal to 1.5mg/dL
  • Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal,
  • Albumin greater than or equal to 3.0mg/dL
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  • Serum creatinine less than or equal to 1.5 mg/dL
  • White Blood Count (WBC) >3,500/mm3; platelets >100,000/mm3; hematocrit (HCT) >32%.
  • INR<1.4 If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • English language speaking
  • Formal education of eight or more years
  • Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening

Who cannot join

  • Serious, active bacterial, fungal or viral infection, active or latent tuberculosis
  • History of severe pulmonary dysfunction
  • 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
  • History of bowel ischemia/perforation, or GI bleeding requiring surgery
  • Hospitalization or change of chronic concomitant medication within one month prior to screening.
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  • History of hemorrhage or infarct or > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.
  • Clinical or laboratory findings consistent with:
  • Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Jacob-Creutzfeld Disease, Down's syndrome, etc.)
  • Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)
  • Seizure disorder
  • History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)
  • Clinically significant abnormal T4 or TSH
  • A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Patients with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
  • Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:
  • Respiratory insufficiency
  • Bradycardia (<45/min.) or tachycardia (>100/min.)
  • Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg)
  • Uncontrolled diabetes defined by HbA1c >8%
  • History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
  • History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
  • Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.).
  • Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg/day, quetiapine ≤100 mg/day, olanzapine ≤5 mg/day, and aripiprazole ≤10 mg/day), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests.
  • Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.
  • Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening
  • Suspected or known allergy to any components of the study treatments.
  • Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.
  • Exposure to passive immunotherapies for AD (e.g. monoclonal antibodies) within the previous 180 days to dosing, and BACE inhibitors within the previous 30 days to dosing.
  • Chronic steroid or interferon therapy
  • Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR >1.4 or other coagulopathy; platelet count of <100,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.
  • Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Alireza Faridar, MD contact

7134411150

afaridar@houstonmethodist.org

United States1 site, 1 recruiting

  • Houston Methodist Research Institute

    Houston, Texas, 77030

    Alireza Faridar, 713-441-1150, afaridar@houstonmethodist.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients With Mild to Moderate Alzheimer's Disease

Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks.

Being tested
Interleukin-2, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

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

  • Interleukin-2Drug

    Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

  • PlaceboDrug

    Placebo administration

Study groups in NCT06096090
Study groupRoleWhat they receive
Aldesleukin every 4 weeksActive comparatorNot described
Receives: Drug: Interleukin-2
Aldesleukin every 2 weeksActive comparatorNot described
Receives: Drug: Interleukin-2
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

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

    Primary endpoint:

    • Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology)

    Measured: 6 months treatment phase

Secondary outcomes (1)

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

    Secondary Endpoint:

    • Change in Treg percentage out of total CD4 cells

    Measured: 6 months treatment phase

Timeline

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

  1. First posted23 Oct 2023
  2. Study start1 Jan 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096090
Sponsor's protocol ID
PRO00030798
Status last verified
May 2024
First submitted
17 Oct 2023
Last updated
23 May 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Faridar A, Gamez N, Li D, Wang Y, Boradia R, Thome AD, Zhao W, Beers DR, Thonhoff JR, Nakawah MO, Roman GC, Volpi JJ, Toledo JB, George M, Davis CS, Pascual B, Grundman M, Masdeu JC, Appel SH. Low-dose interleukin-2 in patients with mild to moderate Alzheimer's disease: a randomized clinical trial. Alzheimers Res Ther. 2025 Jul 4;17(1):146. doi: 10.1186/s13195-025-01791-x.

    PubMed 40615880

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-2 in people with Alzheimer Disease, run by The Methodist Hospital Research Institute at 1 site in United States.

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 31 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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 United States. 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?

Results are not available in the source record.

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

Contact Alireza Faridar, MD (7134411150, afaridar@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and the tolerability of IL-2 in AD patients (time frame: 6 months treatment phase). 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 NCT06096090, which also lists 1 linked publication.

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 23 May 2024.

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