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Идёт набор NCT06338397

Social & Affective Cognition in Alzheimer's Disease & Associated Disorders

Без фазы С лечением Alzheimer's Disease Frontotemporal Degeneration (Semantic & Behavioral Variants)

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: SCANN.
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease, Frontotemporal Degeneration (Semantic & Behavioral Variants). Базовые параметры: 40 лет — 85 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
Франция
Следующий шаг
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Официальное название

Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders

Обзор

Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains.

Вмешательства

  • Другое SCANN
    Administering 11 tests of social \& affective cognition to each participant as well as 6 scales to their study-partner, in order to have a detailed profile of social \& affective cognitive abilities that we can correlate to an 3DMRI with resting state procedure.

Первичные конечные точки

  • Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants. [Срок оценки: 1day]
Вторичные конечные точки (5)
  • Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants. [Срок оценки: 1 day]
  • Correlation coefficient between the SBOC score with MRI markers in all participants [Срок оценки: 1 day]
  • Correlation coefficient between mini-SEA sub scores & MRI markers in all participants. [Срок оценки: 1 day]
  • Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. [Срок оценки: 1 day]
  • Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Men and women;
  • 40 to 85 years of age (included);
  • Registered with the French Social Security;
  • Have a study partner. The study partner is required to complete several scales. If the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor.
  • Fluent in French, able to read and write;

Критерии исключения

  • Participants who have contraindications to perform an MRI scan;
  • Participants with significant sensory deficits that are not corrected by suitable devices.
  • Participants with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load, in the judgment of the investigator;
  • Participants with other neurodegenerative disease such as Lewy body dementia and Parkinson's disease;
  • Participants with other serious neurological disorder such as brain tumor, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
  • Participants with excessive alcohol intake or drug abuse, in the judgment of the investigator;
  • Participants who, in the opinion of the investigator, have a risk of non-compliance to the study procedures;

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Lille University Hospital — Lille

Идентификаторы

NCT: NCT06338397 · 2023_0455

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗