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El ensayo clínico NCT06741553 para Enfermedad de Alzheimer, Deterioro cognitivo leve (MCI) está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab 120 Basado en biomarcadores

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06741553 es un estudio observacional para Enfermedad de Alzheimer, Deterioro cognitivo leve (MCI). Su estado actual es: reclutando. El estudio se inició el 28 de junio de 2024, con el objetivo de reclutar a 120 participantes. Dirigido por Second Affiliated Hospital, School of Medicine, Zhejiang University, se espera que finalice el 1 de junio de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de septiembre de 2025.
Resumen
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...Mostrar más
Título oficial

A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population

Condiciones médicas
Enfermedad de AlzheimerDeterioro cognitivo leve (MCI)
Otros ID del estudio
  • 2024-1113
  • 82371190 (Otra financiación) (National Natural Science Foundation of China)
Número del NCT
NCT06741553
Inicio del estudio (real)
2024-06-28
Última actualización
2025-09-03
Fecha de finalización (estimada)
2027-06
Inscripción (prevista)
120
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
Alzheimer Disease
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
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...Mostrar más
Lecanemab 10 mg/kg
Lecanemab was administered 10mg/kg every two weeks.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño, Adulto, Adulto mayor
Criterios de sexo
Todos
  • 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 University logoSecond Affiliated Hospital, School of Medicine, Zhejiang University
Contactos centrales del estudio
Contacto: Yanxing Chen, M.D., +86 188 6840 1257, [email protected]
1 Centros del estudio en 1 países

Zhejiang

Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Yanxing Chen, MD, Contacto, +86 188 6840 1257, [email protected]
Reclutando