計劃書編號100-4313A
2012-01-01 - 2012-12-31
Phase II
終止收納1
ICD-10G30.0
早發型阿茲海默氏病
ICD-10G30.1
晚發型阿茲海默氏病
ICD-10G30.8
其他阿茲海默氏病
ICD-10G30.9
非特定的阿茲海默氏病
ICD-9331.0
阿茲海默氏病
輕微創傷性腦傷後類澱粉蛋白堆積
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試驗申請者
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試驗委託 / 贊助單位名稱
長庚醫院人體試驗倫理委員會
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臨床試驗規模
台灣多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 終止收納
適應症
阿茲海默病
試驗目的
近年來流行病學研究指出，不論TBI患者是否有失智症的家族病史，TBI皆會增加失智症(尤其是Alzheimer’s disease, AD)的風險，而Aβ的累積在AD初期便佔有重要的地位，其可能與neuron、astrocyte及microglia內的氧化與發炎反應有關。目前許多研究也指出TBI會增加腦內類澱粉蛋白-β的堆積，這些病理變化發現合理解釋TBI在AD可能的角色，但在mTBI病人族群病理組織不易取的，過去的研究較少。然而，隨著類澱粉蛋白－正子攝影的發展，利用葡萄糖代謝腦造影(F-18 FDG PET)可以即早探知阿茲海默症腦部異常代謝病灶。除此，目前研發中的F-18-AV-45核醫造影劑可結合在澱粉樣蛋白上，利用核子醫學掃描技術，將有機會早期探究病患腦中澱粉樣蛋白沈積狀況，同時，還可以做為未來治療阿茲海默症的生物標幟。
藥品名稱
[18F]AV-45
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 mCi
評估指標
主要納入條件
A.Inclusion criteria
a.had TBI in 1, 5, 10 and 15 years ago
b.mild injury in TBI (initial GCS = 13–15)
c.had MRI or CT evaluation after TBI
d.aged 18 years or older (55 years better)
e.have agreement and have signed the informed consent form by him/herself or his/her legal
B.Exclusion criteria
a.participating in another clinical trials which might interfere the current finding
b.not sure the timing of TBI
c.contaminant the symptoms with injury, skull fracture, intracranial hemorrhage,
craniotomy,and death
d.moderate (initial GCS = 9–12) or severe (initial GCS < 8) injury in TBI
e.had wound with gunshot or puncture
f.loss of consciousness over 30 minutes after TBI
g.loss of memory for over 1 day after TBI
h.have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI
or CT evaluation
i.have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and
other major diseases
j.pregnant woman or emotional instability
k.the age less than 18 years (55 years better)
l.unable to collect blood sample by peripheral vein
a.had TBI in 1, 5, 10 and 15 years ago
b.mild injury in TBI (initial GCS = 13–15)
c.had MRI or CT evaluation after TBI
d.aged 18 years or older (55 years better)
e.have agreement and have signed the informed consent form by him/herself or his/her legal
B.Exclusion criteria
a.participating in another clinical trials which might interfere the current finding
b.not sure the timing of TBI
c.contaminant the symptoms with injury, skull fracture, intracranial hemorrhage,
craniotomy,and death
d.moderate (initial GCS = 9–12) or severe (initial GCS < 8) injury in TBI
e.had wound with gunshot or puncture
f.loss of consciousness over 30 minutes after TBI
g.loss of memory for over 1 day after TBI
h.have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI
or CT evaluation
i.have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and
other major diseases
j.pregnant woman or emotional instability
k.the age less than 18 years (55 years better)
l.unable to collect blood sample by peripheral vein
試驗計畫預計收納受試者人數
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台灣人數
40 人
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全球人數
0 人
