이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 5월 20일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

중재적

등록 (추정된)

10

단계

  • 2 단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
[¹⁸F]F-AraG uptake in the brain of patients with AD
기간: 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
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Systemic [¹⁸F]F-AraG uptake in patients with AD
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 16일

기본 완료 (추정된)

2029년 9월 16일

연구 완료 (추정된)

2029년 12월 16일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다