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Идёт набор NCT06546488

Cognitive Assessment Tools for Huntington's Disease.

— Наблюдательное Huntington 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: Assessments.
Кому может быть актуально
Состояния в реестре: Huntington Disease. Базовые параметры: 30 лет — 65 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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Официальное название

Cognitive Assessment Tools for Individuals With Huntington's Disease.

Обзор

The purpose of the current proposal is to expand understanding of two currently available cognitive tools that are not typically used in Huntington Disease (HD) clinical trials that might be useful both for initial screening and for clinical trial application. One is the Coding Test and the other is the Self-Administered Gerocognitive Examination (SAGE). Both the Coding Test and the SAGE have been used for assessments of individuals with other neurodegenerative diseases, including Alzheimer's Disease, Parkinson's Disease and Lewy Body Disease, but data is lacking on their use in individuals with HD.

Подробное описание

Subjects will be recruited from the OSU Wexner Medical Center Huntington Society of America Center of Excellence Clinic. Subjects will be scheduled for a one-time visit to complete the study. The entire visit will take approximately 1-1.5 hours. Vital signs (weight, blood pressure, temperature, respiratory rate and pulse) will be conducted. The subject's medical records will be reviewed to obtain their demographics, current medications, medical/surgical/ HD family history, and HD diagnosis details. If any adverse events occur during the research visit they will be documented. Participants will complete cognitive, functional and motor assessments.

Вмешательства

  • Поведенческое Assessments
    A standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments.

Первичные конечные точки

  • Symbol Digit Modality Test (SDMT) compared to the Coding Test [Срок оценки: One day visit]
  • Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores [Срок оценки: One day visit]
Вторичные конечные точки (3)
  • Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores. [Срок оценки: One day visit]
  • Comparison of Total Motor Chorea sub-score, a part of the Unified Huntington's Disease Rating Scale (UHDRS) total score and scores on the Symbol Digit Modality Test (SDMT), Coding and Self-Administered Gerocognitive Examination (SAGE). [Срок оценки: One day visit]
  • Correlation of age of HD symptom onset and SAGE scores [Срок оценки: One day visit]

Критерии участия

Критерии включения

  • Males and females aged 30-65 (inclusive) at the time of signing the informed consent form.
  • Genetic diagnosis of HD as defined by a CAG repeat size ≥ 40.
  • A clinical diagnosis of HD as defined by a Diagnostic Confidence Level (DCL) of 4.
  • Vision and hearing sufficient for compliance with tests.
  • On a stable dose of medications for 30 days prior to the time of signing the informed consent form.

Критерии исключения

  • Age of symptom onset less than 19 years old or greater than 60 years old.
  • Any serious neurological disorder aside from HD, including but not limited to Alzheimer's disease, Parkinson's disease, Frontotemporal dementia, Lewy body dementia, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury… etc. that in the opinion of the investigator is clinically significant.
  • Any ongoing serious medical condition that in the opinion of the investigator is clinically significant. This includes autoimmune diseases, ongoing treatment for cancer, congestive heart failure, severe pulmonary disease, or any history of a seizure disorder (including the need to take anti-epileptics to prevent seizure).
  • Subjects who are pregnant or breast feeding
  • Subjects with a history of a learning disability.
  • Subjects who are unable to provide consent.

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

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT06546488 · 2024H0192

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗