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Идёт набор NCT06817395

Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

— Наблюдательное Immune Thrombocytopenia

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Immune Thrombocytopenia. 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
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Официальное название

Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)

Обзор

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is: Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery? To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

Подробное описание

This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.

Первичные конечные точки

  • Impairment of fluid cognition [Срок оценки: Baseline]
Вторичные конечные точки (1)
  • Feasibility of longitudinal assessments [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Adults aged ≥ 18 years
  • A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts <50 x 109/L on two occasions in the preceding 3 to 12 months or >12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.
  • Ability to follow instructions in English.

Критерии исключения

  • Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease.
  • Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse.
  • Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer.
  • Brain tumor or cranial surgery within the past year.
  • Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Публикации

  • Frith J, Watson S, Bolton Maggs PH, Newton JL. Cognitive symptoms are common in immune thrombocytopenia and associate with autonomic symptom burden. Eur J Haematol. 2012 Mar;88(3):224-8. doi: 10.1111/j.1600-0609.2011.01730.x. Epub 2011 Dec 12. PMID 22044734
  • Mitchell E, Frith J, Newton J. Fatigue and cognitive impairment in immune thrombocytopenic purpura remain stable over time: short report from a longitudinal study. Br J Haematol. 2019 Sep;186(5):777-781. doi: 10.1111/bjh.15993. Epub 2019 May 23. PMID 31119732
  • Kuter DJ, Khan U, Maruff P, Daak A. Cognitive impairment among patients with chronic immune thrombocytopenia. Br J Haematol. 2024 Jul;205(1):291-299. doi: 10.1111/bjh.19495. Epub 2024 May 9. PMID 38724473

Идентификаторы

NCT: NCT06817395 · 2024P000181

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗