- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05105542
M1 정신분열병 PET 연구
정신분열증에서 무스카린성 M1 수용체 가용성 및 인지
연구 개요
상세 설명
사후 연구에서 수렴된 증거는 뇌 무스카린성 M1 수용체 결핍이 정신분열병(SZ) 환자의 하위 집합에 존재한다는 강력한 증거를 제공합니다. M1 수용체는 SZ의 인지 결핍에 대한 중요한 표적입니다. 그러나 지금까지 생체 내에서 M1 수용체 가용성과 관련하여 SZ의 이질성을 조사하는 것은 불가능했습니다. Yale PET Center에서 새로운 양전자 방출 단층 촬영(PET) 리간드, [11C]EMO의 개발은 처음으로 SZ에서 생체 내 뇌 무스카린성 M1 수용체 가용성을 조사하고 동시에 관계를 설명할 수 있는 독특한 기회를 제공합니다. SZ의 인지 결핍에 대한 M1 수용체의.
연구자들은 [11C]EMO와 인간 두뇌 이미징에 사용할 수 있는 고감도 및 해상도를 갖춘 PET 스캐너인 HRRT(High Resolution Research Tomograph)를 사용하여 SZ 환자와 연령, 성별이 일치하는 건강한 대조군에서 M1 수용체 가용성을 비교할 것입니다. 이 연구는 해마 [11C]EMO 결합(해마 M1 AChR 가용성의 척도), 언어 기억 작업 중 인코딩 관련 γ 전력, 언어 기억, 성별 및 혈청 아세틸콜린 수준 사이의 관계를 탐구할 것입니다. 이 탐색 연구는 M1 수용체 가용성과 관련하여 SZ의 이질성을 완전히 조사하기 위해 더 큰 연구를 수행하는 데 필요한 파일럿 데이터를 제공할 것입니다.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06519
- Connecticut Mental Health Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- DSM-5 정신분열병 또는 정신분열정동장애 진단을 제외하고 신체적, 정신적으로 건강한 18-55세의 남녀
- MRI 스캔 중 위험을 초래할 수 있는 신체에 금속이 없는 피험자
- 두부 외상 및 출혈 장애를 포함한 중요한 병력 없음
제외 기준:
- 임상적으로 중요한 의학적 상태의 병력이 있거나 존재하는 남성 및 여성
- 5일 동안 담배를 끊지 못하는 흡연자
- 밀실 공포증을 앓고 있거나 MRI와 호환되지 않는 임플란트를 가지고 있거나 MRI 및 PET 스캔에 대한 기타 금기 사항이 있는 사람
공부 계획
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 |
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실험적: 11C-EMO - 무스카린성 M1 수용체를 위한 새로운 PET 방사성 추적자
참가자는 [11C]EMO ≤ 20mCi로 단일 PET 스캔을 받게 됩니다.
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방사성 추적자 [11C]EMO는 각 PET 스캔 시작 시 투여됩니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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해마 M1 가용성
기간: 10 일
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[11C]EMO 가용성(BPND)으로 측정
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10 일
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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유발 된 ɣ 진동
기간: 10 일
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EEG로 측정
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10 일
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구두 기억
기간: 10 일
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인지 평가로 측정
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10 일
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Rajiv Radhakrishnan, MD, Yale University
간행물 및 유용한 링크
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연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
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처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000031171
- 1R21MH123870-01A1 (미국 NIH 보조금/계약)
- 1R01MH113557-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .