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

NCT07611357 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CST_Neuro_201_UCD
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alzheimer Disease (AD)

Outcome Measures

Primary Outcomes (3)

• [¹⁸F]F-AraG uptake in the brain of patients with AD

  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

  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

  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)

Secondary Outcomes (2)

• Systemic [¹⁸F]F-AraG uptake in patients with AD

  Imaging visit (~70 minutes)

• Systemic [¹⁸F]F-AraG uptake kinetics in patients with AD

  Imaging visit (~70 minutes)

Study Arms (1)

Arm 1: Alzheimer's Disease Participants

EXPERIMENTAL

Receive \[18F\]F-AraG PET/CT imaging

Drug: Drug: [18F]F-AraG (PET tracer)

Interventions

Drug: [18F]F-AraG (PET tracer) DRUG

Dose: \~5 mCi IV bolus. Procedure: Total-body PET/CT dynamic imaging. Blood samples will be collected during scan.

Arm 1: Alzheimer's Disease Participants

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years
• 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.
• Able to tolerate a PET scan, and willingness and ability to comply with all protocol required procedures.
• 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
• Subjects with possible or probable AD based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD.
• Have a study partner who has significant interaction with the subject and can report on the subject's activities of daily living.

You may not qualify if:

• Clinically significant psychiatric disease other than depression.
• Structural brain abnormalities on MRI (e.g. large infarct or mass) likely to interfere with interpretation of a PET scan.
• History of significant alcohol or substance abuse/dependence within the past 5 years.
• Non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the PET imaging session.
• Current or recent investigational drug use, defined as receiving any investigational medications or participation in another investigational drug trial within the last 30 days.
• Serious comorbidities (malignant and nonmalignant disease or other conditions) that in the opinion of the investigator could compromise study objectives.
• 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.
• 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.
• Prior allogeneic stem cell or solid organ transplant.
• Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
• Active systemic autoimmune diseases.
• Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).
• Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
• Body weight is more than 240 kg (529 pounds)
• Recent use of medications containing guanosine or cysteine analogs.

Sponsors & Collaborators

• CellSight Technologies, Inc.: lead
• University of California, Davis: collaborator

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 28, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): September 16, 2029
• Study Completion (Estimated): December 16, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05