- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01554202
Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)
Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging
According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.
Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.
The three main objectives of this project are
- to identify, compare and combine predictive markers of Alzheimer's disease
- to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
- to study the ability of different neuroimaging techniques to follow the evolution of this pathology.
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Caen, 프랑스, 14033
- University Hospital Côte de Nacre
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Lille, 프랑스, 59037
- University Hospital Roger Salengro
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Rennes, 프랑스, 35033
- University Hospital Pontchaillou
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Rouen, 프랑스, 76031
- University Hospital Rouen
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Tours, 프랑스, 37044
- university hospital Tours
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Education level > 7 years
- Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
- Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).
Exclusion Criteria:
- The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
- A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
- A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
- A medication that may interfere with memory or metabolic measures
- A alcohol or drugs abuse
- claustrophobia, metallic object in the body
- A predominantly left-hand (score below 50% in Edinburgh Inventory).
- Protected adults, and persons not affiliated with a social security system will not participate in this study.
- The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Middle age controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Elderly controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Autosomal dominant forms of early-onset Alzheimer disease
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Subjectif Cognitive Impariment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Mild Cognitive Impairment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Alzheimer Disease patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Non degenerative amnsesic syndrome
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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실험적: Frontotemporal lobe dementia
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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전체 뇌, 해마 및 기타 구조적 MRI 측정의 부피 변화율
기간: 3 년
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3 년
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다음으로 측정한 감소율: 인지 테스트, 일상 생활 활동, CDR Sum of Boxes
기간: 3 년
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3 년
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지정된 각 생화학적 바이오마커의 변화율
기간: 3 년
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3 년
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포도당 대사 변화율(FDG-PET)
기간: 3 년
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3 년
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18F-AV45로 측정한 아밀로이드 침착 정도
기간: 3 년
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3 년
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각 이미징 및 바이오마커 측정에 대한 그룹 차이
기간: 3 년
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3 년
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APOE 유전자형
기간: 3 년
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3 년
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.
- Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.
- La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.
- Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
알츠하이머병에 대한 임상 시험
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L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
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UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
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Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
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Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
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Jiulongpo No.1 People's HospitalJiangxi Maternal and Child Health Hospital아직 모집하지 않음
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Novartis Pharmaceuticals모병류마티스 관절염 (RA) 및 Sjögren 's Disease (SJD)스페인, 프랑스, 독일, 싱가포르
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University of PennsylvaniaEUSA Pharma, Inc.; Castleman Disease Collaborative Network모병캐슬맨병 | 캐슬맨병 | 거대 림프절 과형성 | 혈관여포 림프 증식증 | 혈관여포 림프절 과형성 | 혈관여포성 림프종 과형성 | GLNH | 과형성, 거대 림프절 | 림프절 과형성, 거인미국
assessment of memory에 대한 임상 시험
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Memorial Sloan Kettering Cancer Center종료됨
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Vanderbilt University Medical Center모집하지 않고 적극적으로
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Augusta University모병
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식