- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01325259
FluoroAv45 Imaging Research-in Alzheimer's Disease (FAIR-AD)
Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.
Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.
Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.
Method: Prospective multicentric study. 65 patients expected to enter the study.
Primary outcome measure: Standard Uptake Volume ratios.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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-
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Caen, 프랑스, 14000
- University Hospital of Caen
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Lille, 프랑스, 59000
- University Hospital of Lille
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Toulouse, 프랑스, 31000
- University Hospital of Toulouse
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Tours, 프랑스, 37000
- University Hospital of Tours
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
- 18 < MMS <= 28 for patients
- 28 <= MMS for healthy volunteers
- study period > 7 years
- native language : french
- signed informed consent
- affiliated to a social security system
Exclusion Criteria:
- alcoholism in medical history
- diabetes
- arterial hypertension (180/100 and more)
- chronical pulmonary disease with hypoxis
- cranial traumatism with loss of consciousness > 15 minutes
- severe depressive syndrome or anxiety
- psychiatric disease in medical history (excepted simple episodes of depression)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Alzheimer's disease
30 patients suffering from Alzheimer's disease
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자기 공명 영상
Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
intravenous injection of 4 MBq/kg of [18F]AV-45
intravenous injection of 100 to 120 MBq of FDG
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실험적: Mild Cognitive Impairment
20 patients suffering from Mild Cognitive Impairment
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자기 공명 영상
Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
intravenous injection of 4 MBq/kg of [18F]AV-45
intravenous injection of 100 to 120 MBq of FDG
|
|
실험적: Control
15 subjects with no cognitive impairment
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자기 공명 영상
Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
intravenous injection of 4 MBq/kg of [18F]AV-45
intravenous injection of 100 to 120 MBq of FDG
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Standard Uptake Value Ratios (SUVr)
기간: inclusion
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Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.
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inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vincent CAMUS, University Hospital of Tours
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .