Набор по приглашению NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

— Наблюдательное Alzheimer Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Lecanemab.
Кому может быть актуально: Состояния в реестре: Alzheimer Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.

Вмешательства

Препарат Lecanemab
Bi-weekly infusions of lecanemab \[exposure\].

Первичные конечные точки

Feasibility of enrollment [Срок оценки: 2 years]
Feasibility of completing visits [Срок оценки: 3 months]
Qualitative experience at 3 months [Срок оценки: 3 months]
Qualitative experience at 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

PLWD who are eligible to receive Lecanemab infusion at our clinics.
Care Partner who provides care for the PLWD who are eligible to receive Lecanemab infusion at our clinics.
Age >=18 years for PLWD and their care partners
Provides informed consent prior to participation.