[18F]F-AraG PET Imaging in Alzheimer's Disease
ConditionAlzheimer Disease (AD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorCellSight Technologies, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Drug: [18F]F-AraG (PET tracer)
DrugDose: \~5 mCi IV bolus. Procedure: Total-body PET/CT dynamic imaging. Blood samples will be collected during scan.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Arm 1: Alzheimer's Disease ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
[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.
Time frame
Imaging visit (~70 minutes)2
[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.
Time frame
Imaging visit (~70 minutes)3
[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.
Time frame
Imaging visit (~70 minutes)Secondary outcomes
1
Systemic [¹⁸F]F-AraG uptake in patients with AD
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.
Time frame
Imaging visit (~70 minutes)2
Systemic [¹⁸F]F-AraG uptake kinetics in patients with AD
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.
Time frame
Imaging visit (~70 minutes)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CellSight Technologies, Inc.
Lead sponsor
University of California, Davis
Collaborator
Source ClinicalTrials.gov
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