計劃書編號219867
NCT Number(ClinicalTrials.gov Identfier)NCT06079190
試驗執行中
2023-10-15 - 2029-09-07
Phase II
尚未開始3
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
一項第2期、平行組別、隨機分配、雙盲、安慰劑對照、3組、多中心治療試驗，評估靜脈輸注GSK4527226 [AL101]相較於安慰劑對初期阿茲海默症患者的療效及安全性。
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試驗申請者
荷商葛蘭素史克藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
荷商葛蘭素史克藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/06/23
試驗主持人及試驗醫院
適應症
阿茲海默症
試驗目的
療效：
評估GSK4527226 劑量1 相較於安慰劑的療效，測量方法為初期阿茲海默症受試者的CDR- SB
藥品名稱
GSK4527226/ AL101
主成份
GSK4527226
劑型
Solution
劑量
50 mg/ml
評估指標
劑量1相較於安慰劑組的受試者CDR-SB自基線期至第52、64及76週的變化
主要納入條件
•體重≥ 45 kg至≤ 120 kg，BMI介於17至34.9 kg/m2(含)。
•受試者必須為2018年NIA-AA研究框架定義之阿茲海默症中因阿茲海默症(AD)造成輕度認知功能障礙(MCI)與輕度阿茲海默失智的臨床分期。
•必須具備以下說明之大腦類澱粉沉積症(A+)證據：陽性正子斷層造影(PET)結果或陽性CSF結果。
•受試者必須符合以下納入條件以定義臨床嚴重度：
a.篩選時MMSE分數介於21至29分(含)之間。
b.CDR-GS為0.5至1.0分。
c.CDR記憶方塊分數為≥ 0.5分
d.WMS-IV LMII情節記憶出現客觀障礙的受試者，判定依據為至少低於年齡調整平均值1個標準差
i.50至64歲≤ 15
ii.65至69歲≤ 12
iii.70至74歲≤ 11
iv.75至79歲≤ 9
v.80至90歲≤ 7
•若受試者正在接受阿茲海默症症狀治療藥物，例如乙醯膽鹼酯酶抑制劑(AChEI) (如愛憶欣®、憶思能®、利憶靈®)或威智®，則篩選前必須維持穩定至少12週，且試驗參與期間預期不會改變劑量。
•若受試者正在接受其他治療阿茲海默症相關症狀或狀況的藥物(如抗憂鬱劑、抗焦慮藥、安眠藥、抗精神病藥)，則篩選前必須維持穩定至少4週，且試驗參與期間預期不會改變劑量。症狀必須經試驗主持人判斷受到適當且穩定控制，且試驗期間藥物預期不會有明顯改變。
•女性受試者未懷孕或哺乳中，且若為具生育能力的女性須使用符合計畫書的避孕方式
•男性受試者須使用符合計畫書的避孕方式
•願意且能夠提供知情同意，其中包括遵守知情同意書及本試驗計畫書中所列的要求和限制。
•有一位可與您建立適當聯繫、能夠提供有關您認知功能能力的正確資訊、同意於回診時提供相關資訊，並可簽署試驗夥伴知情同意書的成年人(「試驗夥伴」)。
•受試者必須為2018年NIA-AA研究框架定義之阿茲海默症中因阿茲海默症(AD)造成輕度認知功能障礙(MCI)與輕度阿茲海默失智的臨床分期。
•必須具備以下說明之大腦類澱粉沉積症(A+)證據：陽性正子斷層造影(PET)結果或陽性CSF結果。
•受試者必須符合以下納入條件以定義臨床嚴重度：
a.篩選時MMSE分數介於21至29分(含)之間。
b.CDR-GS為0.5至1.0分。
c.CDR記憶方塊分數為≥ 0.5分
d.WMS-IV LMII情節記憶出現客觀障礙的受試者，判定依據為至少低於年齡調整平均值1個標準差
i.50至64歲≤ 15
ii.65至69歲≤ 12
iii.70至74歲≤ 11
iv.75至79歲≤ 9
v.80至90歲≤ 7
•若受試者正在接受阿茲海默症症狀治療藥物，例如乙醯膽鹼酯酶抑制劑(AChEI) (如愛憶欣®、憶思能®、利憶靈®)或威智®，則篩選前必須維持穩定至少12週，且試驗參與期間預期不會改變劑量。
•若受試者正在接受其他治療阿茲海默症相關症狀或狀況的藥物(如抗憂鬱劑、抗焦慮藥、安眠藥、抗精神病藥)，則篩選前必須維持穩定至少4週，且試驗參與期間預期不會改變劑量。症狀必須經試驗主持人判斷受到適當且穩定控制，且試驗期間藥物預期不會有明顯改變。
•女性受試者未懷孕或哺乳中，且若為具生育能力的女性須使用符合計畫書的避孕方式
•男性受試者須使用符合計畫書的避孕方式
•願意且能夠提供知情同意，其中包括遵守知情同意書及本試驗計畫書中所列的要求和限制。
•有一位可與您建立適當聯繫、能夠提供有關您認知功能能力的正確資訊、同意於回診時提供相關資訊，並可簽署試驗夥伴知情同意書的成年人(「試驗夥伴」)。
主要排除條件
Exclusion Criteria:
Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.
History or presence of vascular disease that has the potential to affect cognitive function.
History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening.
History of severe, clinically significant central nervous system (CNS) trauma.
History or presence of intracranial tumor.
Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae.
History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments.
Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years.
Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years
Magnetic resonance imaging (MRI) evidence based on central read of:
>3 lacunar infarcts.
Stroke involving a major vascular territory, severe small vessel, or white matter disease.
Any territorial /cortical/other infarct >1 cubic centimetre (cm^3).
White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3
>4 microhaemorrhages.
Any areas of superficial (leptomeningeal) hemosiderosis.
A single macro-hemorrhage greater than 10 millimetres (mm) at greatest diameter.
Vasogenic edema.
Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions.
Space occupying lesions or brain tumors.
Significant cerebral vascular pathology
Hydrocephalus/Normal pressure hydrocephalus.
Other MRI findings contraindicating participation in the study such as subarachnoid hemorrhage.
History suggestive of exposure to, or past tuberculosis (TB) infection should undergo screening for TB disease.
Chronic active immune disorder requiring systemic immunosuppressive therapy within 6 months prior to Screening.
Screening serum vitamin B12 concentration < Lower limit of normal (LLN) or in the low normal range
Folate Upper limit of normal (ULN)
Hemoglobin A1c >8 percentage (%) or poorly controlled diabetes during the last 12 weeks
History of cancer
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Planned surgery during the study which requires general, spinal, or epidural anesthesia that would take place during the study.
Known genetic predisposition for clotting disorder or hemorrhagic disease.
Key exclusionary medications include:
Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, mood stabilizers, or stimulants that are used on a chronic basis, are exclusionary if not consistent with the following rule: treatment has to have been at a stable dose for at least 4 weeks before screening and should remain stable during the study
Any biologic drugs with systemic exposure, whether investigational or approved, used within 6 months before screening Any disease modification drug for AD, such as aducanumab and lecanemab, whether investigational or approved, used within 6 months before screening.
Anticoagulation medications within 90 days of screening and during the study
Systemic immunosuppressive therapy within 6 months before screening and during the study.
Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.
History or presence of vascular disease that has the potential to affect cognitive function.
History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening.
History of severe, clinically significant central nervous system (CNS) trauma.
History or presence of intracranial tumor.
Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae.
History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments.
Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years.
Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years
Magnetic resonance imaging (MRI) evidence based on central read of:
>3 lacunar infarcts.
Stroke involving a major vascular territory, severe small vessel, or white matter disease.
Any territorial /cortical/other infarct >1 cubic centimetre (cm^3).
White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3
>4 microhaemorrhages.
Any areas of superficial (leptomeningeal) hemosiderosis.
A single macro-hemorrhage greater than 10 millimetres (mm) at greatest diameter.
Vasogenic edema.
Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions.
Space occupying lesions or brain tumors.
Significant cerebral vascular pathology
Hydrocephalus/Normal pressure hydrocephalus.
Other MRI findings contraindicating participation in the study such as subarachnoid hemorrhage.
History suggestive of exposure to, or past tuberculosis (TB) infection should undergo screening for TB disease.
Chronic active immune disorder requiring systemic immunosuppressive therapy within 6 months prior to Screening.
Screening serum vitamin B12 concentration < Lower limit of normal (LLN) or in the low normal range
Folate
Hemoglobin A1c >8 percentage (%) or poorly controlled diabetes during the last 12 weeks
History of cancer
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Planned surgery during the study which requires general, spinal, or epidural anesthesia that would take place during the study.
Known genetic predisposition for clotting disorder or hemorrhagic disease.
Key exclusionary medications include:
Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, mood stabilizers, or stimulants that are used on a chronic basis, are exclusionary if not consistent with the following rule: treatment has to have been at a stable dose for at least 4 weeks before screening and should remain stable during the study
Any biologic drugs with systemic exposure, whether investigational or approved, used within 6 months before screening Any disease modification drug for AD, such as aducanumab and lecanemab, whether investigational or approved, used within 6 months before screening.
Anticoagulation medications within 90 days of screening and during the study
Systemic immunosuppressive therapy within 6 months before screening and during the study.
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
365 人
