NCT07611357Toborzás még nem indult2. fázis
[18F]F-AraG PET Imaging in Alzheimer's Disease
Total-Body [18F]F-AraG PET/CT Imaging to Quantify CNS and Systemic T Cell Involvement in Alzheimer's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 28.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2026. máj. 1.
- Kezdés
- 2026. máj. 16.
- Elsődleges befejezés
- 2029. szept. 16.
- Fő szponzor
- CellSight Technologies, Inc.
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT07611357
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 10
- 2026. máj. 16. és az elsődleges befejezés (2029. szept. 16.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
- Prior allogeneic stem cell or solid organ transplant.
- Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
- Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
- Recent use of medications containing guanosine or cysteine analogs.
Más betegség
- Clinically significant psychiatric disease other than depression.
- History of significant alcohol or substance abuse/dependence within the past 5 years.
- 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.
- Active systemic autoimmune diseases.
- Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).
Laborértékek
- 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.
Egyéb
- Structural brain abnormalities on MRI (e.g. large infarct or mass) likely to interfere with interpretation of a PET scan.
- Body weight is more than 240 kg (529 pounds)
- Any other criteria which would make the participant unsuitable for study participation, as determined by the Principal Investigator.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 55 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.