RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing IL-2 (Aldesleukin) for Alzheimer Dementia (AD)

Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited.

Official registry: https://clinicaltrials.gov/study/NCT07651319 · The Methodist Hospital Research Institute · enrollment listed as 30

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IL-2 (Aldesleukin), Semaglutide Plus IL-2, or Placebo. The registry lists allocation as randomized. Alzheimer's disease (AD) is the most common cause of dementia.

They plan to enroll about 30 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase Ib Clinical Trial, Using Interleukin-2 (IL-2) and Semaglutide in Patients With Alzheimer's Disease

Interventions: IL-2 (Aldesleukin), Semaglutide Plus IL-2, Placebo

Primary outcome (registry wording): Evaluate the Incidence of Treatment-Emergent Adverse Events of IL-2 plus Semaglutide in AD patients

Who it is for (from inclusion criteria)

Ages 50 Years to 86 Years
Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13
Male or female age 50 to 86 years
Albumin greater than or equal to 3.0mg/dL
White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%
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

Who the registry excludes

Any untreated bacterial, fungal or viral infection
Renal dysfunction indicated by serum creatinine greater than 1.5 mg/dL
Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal
Hypersensitivity or allergy to IL-2
History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening
Clinical or laboratory findings consistent with:
Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)

Public study contact (from the registry)

Alireza Alireza, MD

713-441-1150

afaridar@houstonmethodist.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Houston Methodist Research Institute — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT07651319 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07651319?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07651319?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary