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Идёт набор NCT07110207

Single-centre Descriptive Study of Taste in Frontotemporal Lobar Degeneration Through the Analysis of Taste Evoked Potentials

Без фазы С лечением Frontotemporal Lobar Degeneration (FTLD)

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: Blood test, Interrogation of the subject, Cognitive assessment, Nutritional assessment.
Кому может быть актуально
Состояния в реестре: Frontotemporal Lobar Degeneration (FTLD). 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The FRONTAL-PEG study focuses on taste perception in frontotemporal lobar degeneration (FTLD). This neurodegenerative disease, characterised by progressive loss of nerve cells, is the second leading cause of dementia after Alzheimer's disease. Patients with FTLD often experience olfactory disorders (= sense of smell) and eating disorders: increased appetite, increased food intake and excessive consumption of sugary foods and snacking. This often leads to excessive weight gain. These eating disorders are still poorly understood at present. In this context, we hypothesise that an alteration in the gustatory pathway - i.e. the way in which the brain perceives taste - could contribute to the eating disorders frequently observed in frontotemporal dementia (FTD), particularly in the marked attraction to sweet foods. We therefore wish to objectively evaluate the taste response to a sweet solution (sucrose) in patients with FTLD, using taste evoked potentials (TEPs). Taste evoked potentials are a reliable and reproducible technique for assessing brain activity in response to taste stimulation. One of their advantages is that they are non-invasive. This study will document, for the first time in this disease, the characteristics of cortical (brain) processing of taste information. The FRONTAL-PEG study is an interventional, regional, single-centre study conducted at the Dijon University Hospital, in collaboration with the CMRR (Memory, Resources and Research Centre) and the CSGA (Centre for Taste and Food Sciences). All investigations are carried out at the CSGA (building adjacent to the Dijon University Hospital), with the exception of blood tests, which are carried out at the Dijon University Hospital. The total duration of participation in the study is one morning. No follow-up is planned at the end of the study.

Вмешательства

  • Биопрепарат Blood test
    Metabolic measurements and measurements of hormones related to food intake
  • Другое Interrogation of the subject
    Collection of socio-demographic data, medical and family history, medication
  • Другое Cognitive assessment
    MMSE and MoCA cognitive tests
  • Другое Nutritional assessment
    Anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skinfold thickness, brachial circumference), bioelectrical impedance analysis (body fat percentage, lean body mass, body water percentage and bone mass in kg)
  • Другое Taste tests
    Recording of PEGs in response to a sucrose solution (prepared beforehand)
  • Другое Sucrose taste detection test
    Triangular test

Первичные конечные точки

  • Average latency of taste evoked potentials [Срок оценки: After a fasting period of at least two hours]

Критерии участия

Критерии включения

  • Person who has given their free and informed consent
  • Person of legal age
  • Fasting > 2 hours before PEG measurement
  • Body Mass Index (BMI) < 30 kg/m² (according to medical record data)
  • DLFT: diagnostic criteria for established or probable DLFT

Критерии исключения

  • Persons not affiliated with or not covered by a social security scheme
  • Persons subject to legal protection measures (guardianship, trusteeship)
  • Persons subject to judicial protection measures
  • Pregnant women, women in labour or breastfeeding women
  • MMSE score < 15 and/or MoCA score < 10
  • Known COVID-19 infection within 6 months prior to inclusion
  • Active smokers (> 4 cigarettes per day on a regular basis)
  • Subject with a pacemaker (contraindication for bioelectrical impedance analysis)
  • Subject with diabetes (type 1 or type 2)
  • Taking medication (during the study) that interferes with taste

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHU Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07110207 · JACQUIN 2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗