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Systemic and Central Inflammation in AD | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Systemic and Central Inflammation in AD

Central and Peripheral Immune Cross-talk in Alzheimer's Disease and Their Modulation by a Novel Immunotherapy

NCT06384378•The Methodist Hospital Research Institute

Summary

Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers.

Eligibility

Age

50 - 86 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
•2. Male or female age 50 to 86 years
•3. MMSE between 12-26
•4. Total bilirubin less than or equal to 1.5mg/dL
•5. Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal,
•6. Albumin greater than or equal to 3.0mg/dL
•7. Serum creatinine less than or equal to 1.5 mg/dL
•8. White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%.
•9. 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.
•10. English language speaking
+2 more criteria

Exclusion Criteria

•1. Serious, active bacterial, fungal or viral infection, active or latent tuberculosis
•2. History of severe pulmonary dysfunction
•3. 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
•4. Hypersensitivity or allergy to IL-2
•5. History of bowel ischemia/perforation, or GI bleeding requiring surgery
•6. Hospitalization or change of chronic concomitant medication within one month prior to screening.
•7. 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.
•8. 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
•9. 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.
+14 more criteria

Locations (1)

Houston Methodist Research Institute

Houston, Texas, United States

Key Dates

Start Date

March 17, 2023

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

April 25, 2024

Enrollment

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

11C-ER176

DRUG

Contacts

Alireza Faridar

CONTACT

7134411150 afaridar@houstonmethodist.org

Maria B Pascual

CONTACT

bpascual@houstonmethodist.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Systemic and Central Inflammation in AD

Inclusion Criteria

Exclusion Criteria

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