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[18F]F-AraG PET Imaging in Alzheimer's Disease

20 de mayo de 2026 actualizado por: CellSight Technologies, Inc.

Total-Body [18F]F-AraG PET/CT Imaging to Quantify CNS and Systemic T Cell Involvement in Alzheimer's Disease

This study evaluates the use of [18F]F-AraG PET/CT imaging to quantify activated T cell involvement in patients with Alzheimer's disease (AD). Participants will undergo total-body dynamic PET imaging to assess tracer uptake in the brain and peripheral organs. Results will be compared between participants with AD and healthy controls to characterize both central nervous system and systemic immune alterations in AD

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

Alzheimer's disease (AD) is known to involve neuroinflammation, but the role of T cell-mediated adaptive immunity remains poorly understood. This study uses [18F]F-AraG, a PET tracer that preferentially accumulates in activated T cells, to noninvasively assess immune-metabolic activity in the brain and peripheral organs in patients with AD.

Participants will undergo high-sensitivity total-body dynamic PET imaging using the uEXPLORER system. Intracerebral and systemic immune-metabolic activity will be assessed by analyzing total body [18F]F-AraG biodistribution and kinetics. .

The study will compare imaging metrics between AD participants and healthy controls.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • Fase 2

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age ≥ 55 years
  2. Prior volumetric brain MRI available. If the prior MRI scan is not acquired within 6 months of [18F]F-AraG imaging or if the investigator determines that prior MRI scan cannot be used, a new MRI scan will be acquired.
  3. Able to tolerate a PET scan, and willingness and ability to comply with all protocol required procedures.
  4. For participants of reproductive potential - defined as individuals who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months), or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy - willingness to use effective double barrier contraceptive methods (excluding withdrawal or timing methods) up to 1 day after the administration of [18F]F-AraG
  5. Subjects with possible or probable AD based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD.
  6. Have a study partner who has significant interaction with the subject and can report on the subject's activities of daily living.

Exclusion Criteria:

  1. Clinically significant psychiatric disease other than depression.
  2. Structural brain abnormalities on MRI (e.g. large infarct or mass) likely to interfere with interpretation of a PET scan.
  3. History of significant alcohol or substance abuse/dependence within the past 5 years.
  4. Non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the PET imaging session.
  5. Current or recent investigational drug use, defined as receiving any investigational medications or participation in another investigational drug trial within the last 30 days.
  6. Serious comorbidities (malignant and nonmalignant disease or other conditions) that in the opinion of the investigator could compromise study objectives.
  7. Conditions affecting immune function or conditions caused by immune system malfunction that could interfere with imaging, including known inflammatory or immune disorders, systemic malignancy, or chronic viral infections.
  8. Pregnant or nursing individuals. All participants of reproductive potential will undergo a urine or HCG serum pregnancy test with a sensitivity of at least 25 mIU/mL at screening and on the day of PET/CT imaging.
  9. Prior allogeneic stem cell or solid organ transplant.
  10. Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
  11. Active systemic autoimmune diseases.
  12. Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).
  13. Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
  14. Body weight is more than 240 kg (529 pounds)
  15. Recent use of medications containing guanosine or cysteine analogs.
  16. Any other criteria which would make the participant unsuitable for study participation, as determined by the Principal Investigator.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1: Alzheimer's Disease Participants
Receive [18F]F-AraG PET/CT imaging
Dose: ~5 mCi IV bolus. Procedure: Total-body PET/CT dynamic imaging. Blood samples will be collected during scan.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
[¹⁸F]F-AraG uptake in the brain of patients with AD
Periodo de tiempo: Imaging visit (~70 minutes)
To assess presence of activated T cells uptake in patients with AD, static frames from PET/CT scans at 50 minutes post-injection will be analyzed to quantify the intracerebral uptake in patients with AD. Standardized uptake values will be reported for patients with AD and will be statistically compared between AD and healthy control participants.
Imaging visit (~70 minutes)
[¹⁸F]F-AraG uptake kinetics in the brain of patients with AD
Periodo de tiempo: Imaging visit (~70 minutes)
To assess kinetics of [¹⁸F]F-AraG uptake in patients with AD, ~70-min dynamic PET/CT scans will be analyzed to generate time-activity curves (TACs) in the brain. Kinetic modeling will be applied to extract uptake kinetic parameters. Uptake kinetics will be reported for patients with AD and will be statistically compared between AD and healthy control participants.
Imaging visit (~70 minutes)
[¹⁸F]F-AraG vascular kinetics in the brain of patients with AD
Periodo de tiempo: Imaging visit (~70 minutes)
To assess vascular kinetics of [¹⁸F]F-AraG in patients with AD, dynamic PET/CT scans will be analyzed with high temporal resolution kinetic modeling in the brain. Vascular kinetic parameters will be reported for patients with AD and will be statistically compared between AD and healthy control participants.
Imaging visit (~70 minutes)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systemic [¹⁸F]F-AraG uptake in patients with AD
Periodo de tiempo: Imaging visit (~70 minutes)
To assess systemic immune activation in patients with AD, static frames from PET/CT scans at 50 minutes post-injection will be analyzed to quantify the whole-body uptake in patients with AD. Standardized uptake values will be reported in multiple tissues for patients with AD and will be statistically compared between AD and healthy control participants.
Imaging visit (~70 minutes)
Systemic [¹⁸F]F-AraG uptake kinetics in patients with AD
Periodo de tiempo: Imaging visit (~70 minutes)
To assess systemic kinetics of [¹⁸F]F-AraG uptake in patients with AD, ~70-min dynamic PET/CT scans will be analyzed to generate time-activity curves (TACs) in the multiple tissues. Kinetic modeling will be applied to extract uptake kinetic parameters. Uptake kinetics in multiple tissues will be reported for patients with AD and will be statistically compared between AD and healthy control participants.
Imaging visit (~70 minutes)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

16 de mayo de 2026

Finalización primaria (Estimado)

16 de septiembre de 2029

Finalización del estudio (Estimado)

16 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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