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임상시험 NCT06741553은(는) 알츠하이머 병, 경도 인지 장애 (MCI)에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab 120 바이오마커 기반
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06741553은(는) 알츠하이머 병, 경도 인지 장애 (MCI)에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2024년 6월 28일에 시작되어 120명의 참여자를 모집하고 있습니다. Second Affiliated Hospital, School of Medicine, Zhejiang University이(가) 진행하며, 2027년 6월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 3일에 갱신되었습니다.
간단한 개요
As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targe...더 보기
공식 제목
A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population
질환명
알츠하이머 병경도 인지 장애 (MCI)기타 연구 식별자
- 2024-1113
- 82371190 (기타 보조금/자금 번호) (National Natural Science Foundation of China)
NCT 번호
실제 연구 시작일
2024-06-28
최신 업데이트 게시
2025-09-03
예상 연구 완료일
2027-06
계획된 등록 인원
120
연구종류
관찰연구
상태
모집중
키워드
Alzheimer Disease
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Lecanemab
Cognition
Amyloid-related imaging abnormalities
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Treated Group This is an observational study. The investigators included early AD patients treated with Lecanemab, and evaluated them by plasma, magnetic resonance imaging (MRI) examination and clinical scale. The investigators observed the changes in MRI characteristics and clinical symptoms of patients after Lecanemab administration, evaluated the improvement effect of Lecanemab on cognitive function, and monitored the risk fact...더 보기 | Lecanemab 10 mg/kg Lecanemab was administered 10mg/kg every two weeks. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CDR-SB Score | All study subjects underwent Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
MMSE | All study subjects underwent Mini Mental State Examination (MMSE) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). MMSE, with total scores ranging from 0 to 30, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
ADCs-ADL | All study subjects underwent Alzheimer's Disease Cooperative Study-Activity of Daily Life (ADCs-ADL) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 78, can be used to measure activity of daily life changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
NPI | All study subjects underwent Neuropsychiatric Inventory (NPI) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Aβ-PET Burden | All study subjects underwent Aβ positron emission tomography (PET) before the 1st dose (V1) ,at 12 and 18 months after treatment (V26,V39). The investigators quantified participants' Aβ burden using the average cortical standard uptake value ratio (SUVR), that is, tracer uptake in medial orbital frontal, lateral temporal, parietal, anterior cingulate, posterior cingulate, and precuneus regions divided by uptake in the cerebellar reference region. | Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39) |
MRI | All study subjects underwent magnetic resonance imaging (MRI) before the 1st dose (V1) ,at 2, 3, 6,12 and 18 months after treatment. The scan includes T1, T2 fluid attenuated inversion recovery (FLAIR, 5 mm slice thickness), susceptibility weighted imaging (SWI, 1 mm slice thickness) and diffusion weighted imaging (DWI). The MRI scan can be used to meature the study subjects' hippocampus atrophy and white matter hyperintensities and to detect whether adverse events such as amyloid-related imaging abnormalities happen. | Time Frame: MRI tested by baseline before the 1st dose(V1) , at 2, 3, 6, 12 and 18 months after treatment (V5, V7, V14, V25, V39) |
Biospecimen | All study subjects underwent blood collection before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) for routine blood tests, liver and kidney function, plasma biomarkers, and other indicators. Among them, the APOE genotype of subjects will be tested before the 1st dose. | Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39) |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
참여 가능한 성별
전체
- Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
- Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;
- Completion of APOE gene testing.
- Willingness to use Lecanemab.
- Unable to tolerate MRI scans;
- MRI showing hemorrhagic manifestations, including >4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;
- Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;
- With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Second Affiliated Hospital, School of Medicine, Zhejiang University연구 대표 연락처
연락처: Yanxing Chen, M.D., +86 188 6840 1257, [email protected]
1 1개국에 임상시험 장소
Zhejiang
Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Yanxing Chen, MD, 연락처, +86 188 6840 1257, [email protected]
모집중