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Alzheimer Disease (AD)Phase 2NCT07611357

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

A Phase 2 study testing Drug: [18F]F-AraG (PET tracer) in people with Alzheimer Disease (AD), run by CellSight Technologies, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer Disease (AD)
What is being tested?
Drug: [18F]F-AraG (PET tracer)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
16 May 2026to 16 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • Any other criteria which would make the participant unsuitable for study participation, as determined by the Principal Investigator.

About this study

Official title: 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

Read the detailed description

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.

Being tested
Drug: [18F]F-AraG (PET tracer)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07611357
Study groupRoleWhat they receive
Arm 1: Alzheimer's Disease ParticipantsExperimentalReceive [18F]F-AraG PET/CT imaging
Receives: Drug: Drug: [18F]F-AraG (PET tracer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Imaging visit (~70 minutes)

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: Imaging visit (~70 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start16 May 2026 (estimated)
  3. Primary completion16 Sep 2029 (estimated)
  4. Study completion16 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07611357
Sponsor's protocol ID
CST_Neuro_201_UCD
Status last verified
May 2026
First submitted
1 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: [18F]F-AraG (PET tracer) in people with Alzheimer Disease (AD), run by CellSight Technologies, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[¹⁸F]F-AraG uptake in the brain of patients with AD (time frame: Imaging visit (~70 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07611357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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