Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab

Официальное название

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

Обзор

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, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.

Вмешательства

• Препарат Lecanemab 10 mg/kg
  Lecanemab was administered 10mg/kg every two weeks.

Первичные конечные точки

• CDR-SB Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)]

Вторичные конечные точки (3)

• Aβ-PET Burden [Срок оценки: Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39)]
• MRI [Срок оценки: 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 [Срок оценки: Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу

Идентификаторы

NCT: NCT06741553 · 2024-1113 · 82371190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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