計劃書編號100-2899A
2011-11-01 - 2018-12-31
Phase II
終止收納1
以18F-AV45核醫造影劑評估頸動脈狹窄患者其腦部灌流不足對於澱粉樣蛋白分佈型態之影響
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試驗申請者
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試驗委託 / 贊助單位名稱
N/A
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臨床試驗規模
台灣單中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
適應症
1.頸動脈狹窄
試驗目的
主要試驗目的：
18F-AV45為美國Avid Radiopharmaceuticals公司研發新一代標記澱粉樣蛋白輔助之新核醫造影劑，證據顯示失智症病患腦中有異常澱粉樣蛋白沈澱，且與致病機轉有關。本研究希望探討因頸動脈狹窄所導致之腦部低血流灌注是否會增加腦部澱粉樣蛋白的形成。
次要試驗目的
藉由長期追蹤，探討頸動脈再開通手術是否能減緩或改善腦部類澱粉蛋白的分佈情況，同時分析這樣的現象是否會與受試者的認知功能改變有相關性。
藥品名稱
(E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine ([18F]AV-45) / 針劑
主成份
(E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine
劑型
針劑
劑量
10
評估指標
主要評估指標：
臨床評估：分析接受頸動脈狹窄患者之腦部澱粉樣蛋白分佈型態:
1. 依照先前在正常中老年受試者，所獲得18F-AV45靜脈注射後的全身分佈，以及該藥物的全身劑量以及藥物動力學資料，來給予18F-AV45。
2. 我們將觀察在頸動脈狹窄患者，18F-AV45注射後其腦中的分佈情況，以瞭解該藥物的在腦部低灌流狀態下的分佈型態。
數據分析：
1.本研究將收集病患的心電圖、基本血液、生化資料，以評估18F-AV45在頸動脈介入性治療前後的安全性。
2.本研究將分析18F-AV45的腦部影像，以探究該新藥物在受試者以及介入性治療
前後的腦部分佈資料。
3.本研究將以動態影像分析18F-AV45在受試者，其腦中的時間活度曲線，以瞭解該新藥物注射後的適切造影時間點，
次要評估指標：
我們將觀察在頸動脈狹窄患者，18F-AV45藥物在頸動脈介入性治療前後，其腦中的分佈有無差異情況，以瞭解頸動脈介入性治療對該藥物的影響。
臨床評估：分析接受頸動脈狹窄患者之腦部澱粉樣蛋白分佈型態:
1. 依照先前在正常中老年受試者，所獲得18F-AV45靜脈注射後的全身分佈，以及該藥物的全身劑量以及藥物動力學資料，來給予18F-AV45。
2. 我們將觀察在頸動脈狹窄患者，18F-AV45注射後其腦中的分佈情況，以瞭解該藥物的在腦部低灌流狀態下的分佈型態。
數據分析：
1.本研究將收集病患的心電圖、基本血液、生化資料，以評估18F-AV45在頸動脈介入性治療前後的安全性。
2.本研究將分析18F-AV45的腦部影像，以探究該新藥物在受試者以及介入性治療
前後的腦部分佈資料。
3.本研究將以動態影像分析18F-AV45在受試者，其腦中的時間活度曲線，以瞭解該新藥物注射後的適切造影時間點，
次要評估指標：
我們將觀察在頸動脈狹窄患者，18F-AV45藥物在頸動脈介入性治療前後，其腦中的分佈有無差異情況，以瞭解頸動脈介入性治療對該藥物的影響。
主要納入條件
The inclusion criteria
1.The severity of operative carotid stenosis according to the NASCET criteria
A.Control group
i.The stenosis degree of bilateral carotid arteries is less then 50%.
B.Medication group
i.The stenosis severity of one of the carotid arteries is 60% or over.
C.Intervention group which includes carotid artery stenting (CAS) and carotid artery
endarterectomy (CEA) (according to the regulations of National Health Insurance
Bureau, Taiwan)
i.For stroke patients, the symptomatic carotid stenosis is 60% or over.
ii.For nonstroke patients, the carotid stenosis is 80% or over.
iii.The stenosis severity of one of the carotid arteries is 60% or over.
2.Age is 50 years or older.
3.The score of National Institutes of Health stroke scale (NIHSS) is 8 or lower.
4.Barthel Index is 80 or higher.
5.Modified Rankin Scale is 3 or lower.
6.Subjects with carotid stenosis >= 60% have vascular cognitive impairment (VCI)
affecting at least 1 cognitive domain (executive/attention, memory, language, and
visuospatial functions).
The exclusion criteria
1.The preoperative clinical dementia rating (CDR) scale is 2 or above.
2.With aphasia or other language disturbance
3.Refuse to sign inform consent
4.Pregnant or becoming pregnant during the study (as documented by pregnancy testing at
screening or at any date during the study according to the PI discretion) or current
breast feeding.
5.Any subject who has a clinically significant abnormal laboratory values, and/or
clinically significant or unstable medical or psychiatric illness, such as suffering
from severe infection, having end stage renal disease (serum creatinine >3 mg%) or under
hemodialysis, life expectancy less than 1 year, and etc.
6.History of drug or alcohol abuse within the last year, or prior prolonged history of
abuse.
7.Patients who have the evidence of neurodegenerative disorders other than vascular
dementia, cognitive impairment resulting from trauma or brain damage, clinically
significant psychiatric disease and epilepsy are excluded.
8.General MRI, PET and/or SPECT exclusion criteria.
1.The severity of operative carotid stenosis according to the NASCET criteria
A.Control group
i.The stenosis degree of bilateral carotid arteries is less then 50%.
B.Medication group
i.The stenosis severity of one of the carotid arteries is 60% or over.
C.Intervention group which includes carotid artery stenting (CAS) and carotid artery
endarterectomy (CEA) (according to the regulations of National Health Insurance
Bureau, Taiwan)
i.For stroke patients, the symptomatic carotid stenosis is 60% or over.
ii.For nonstroke patients, the carotid stenosis is 80% or over.
iii.The stenosis severity of one of the carotid arteries is 60% or over.
2.Age is 50 years or older.
3.The score of National Institutes of Health stroke scale (NIHSS) is 8 or lower.
4.Barthel Index is 80 or higher.
5.Modified Rankin Scale is 3 or lower.
6.Subjects with carotid stenosis >= 60% have vascular cognitive impairment (VCI)
affecting at least 1 cognitive domain (executive/attention, memory, language, and
visuospatial functions).
The exclusion criteria
1.The preoperative clinical dementia rating (CDR) scale is 2 or above.
2.With aphasia or other language disturbance
3.Refuse to sign inform consent
4.Pregnant or becoming pregnant during the study (as documented by pregnancy testing at
screening or at any date during the study according to the PI discretion) or current
breast feeding.
5.Any subject who has a clinically significant abnormal laboratory values, and/or
clinically significant or unstable medical or psychiatric illness, such as suffering
from severe infection, having end stage renal disease (serum creatinine >3 mg%) or under
hemodialysis, life expectancy less than 1 year, and etc.
6.History of drug or alcohol abuse within the last year, or prior prolonged history of
abuse.
7.Patients who have the evidence of neurodegenerative disorders other than vascular
dementia, cognitive impairment resulting from trauma or brain damage, clinically
significant psychiatric disease and epilepsy are excluded.
8.General MRI, PET and/or SPECT exclusion criteria.
試驗計畫預計收納受試者人數
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台灣人數
160 人
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全球人數
0 人
