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Идёт набор NCT06104852

Triage Survey for Neurology Research Eligibility

— 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: Survey, Optional Medication Washout.
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

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

Подробное описание

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials. Secondary objectives include identifying participant characteristics among the clinical trial-seeking population, identifying the percentage of potential participants currently taking prescribed memory medications that could exclude them from clinical trial participation, examining how changes in prescription memory medications impact performance on cognitive assessments, and identifying the percentage of potential participants whose laboratory results could exclude them from clinical trial participation.

Вмешательства

  • Другое Survey
    Participants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected.
  • Другое Optional Medication Washout
    Participants taking memory medications which require a down-taper per the judgment of the study physicians may participate in a medication washout period during study screening.

Первичные конечные точки

  • Proportion of the clinical trial seeking population for whom industry-sponsored clinical research is clinically appropriate, as defined as those who go on to screen for a study. [Срок оценки: Up to 52 weeks]
Вторичные конечные точки (3)
  • Proportion of the clinical trial seeking population who enroll in industry-sponsored studies. [Срок оценки: Up to 52 weeks]
  • Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications. [Срок оценки: Up to 52 weeks]
  • Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications. [Срок оценки: Up to 52 weeks]

Критерии участия

Критерии включения

  • Participant and study partner (when applicable) have signed an ICF prior to study-specific procedures being performed.
  • Participant and study partner (when applicable) are at least 18 years old.

Критерии исключения

  • Participant lacks the language skills or cognitive ability to understand the screening process.
  • Participant is pregnant, breast-feeding, or planning to become pregnant.
  • History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
  • Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on Columbia-Suicide Severity Rating Scale questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
  • Moderate or severe substance use disorder within 90 days prior to screening, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
  • Any condition that in the investigator's opinion makes a participant unsuitable for the study.
  • Currently employed by Adams Clinical or a first-degree relative of an employee working on this study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 3 центра
  • Copley Clinical — Boston
  • Adams Clinical — Watertown
  • Berman Clinical — New York

Идентификаторы

NCT: NCT06104852 · TRIAGE-Neuro-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗