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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Caen、フランス、14000
- University Hospital of Caen
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Lille、フランス、59000
- University Hospital of Lille
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Toulouse、フランス、31000
- University Hospital of Toulouse
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Tours、フランス、37000
- University Hospital of Tours
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Alzheimer's disease
30 patients suffering from Alzheimer's disease
|
磁気共鳴画像
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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実験的：Mild Cognitive Impairment
20 patients suffering from Mild Cognitive Impairment
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磁気共鳴画像
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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実験的：Control
15 subjects with no cognitive impairment
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磁気共鳴画像
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Standard Uptake Value Ratios (SUVr)
時間枠：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.
|
inclusion
|
協力者と研究者
捜査官
- 主任研究者：Vincent CAMUS、University Hospital of Tours
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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