Меню
Идёт набор NCT05740683

Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA

— Наблюдательное Idiopathic Anosmia Idiopathic Hyposmia Idiopathic Olfactory Dysfunction

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: RT-QuiC.
Кому может быть актуально
Состояния в реестре: Idiopathic Anosmia, Idiopathic Hyposmia, Idiopathic Olfactory Dysfunction. Базовые параметры: 55 лет — 75 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction

Подробное описание

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. DLB is like Parkinson's disease (PD), characterized by the accumulation of alpha-synuclein, which misfolds and aggregates within neurons in so-called Lewy Bodies; this assumably drives the neurodegeneration. A novel technique for the measurement of misfolded alpha-synuclein is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process as well as aid in identifying patients with prodromal DLB. This would enable earlier symptomatic relief and care and potentially promote the search for disease-modifying therapies, which is currently absent.

Objectives. The overarching objective of this project is to identify early clinical warning signs and biomarkers in prodromal DLB.

Method. Study 1: Exploratory cross-sectional case-control study of patients with olfactory dysfunction versus individuals without olfactory dysfunction assessing pathological alpha-synuclein by RT-QuIC and prodromal symptoms of DLB and Parkinson's Disease.

Study 2: Longitudinal follow-up in Danish registries on diagnosing PD and dementia.

Вмешательства

  • Диагностический тест RT-QuiC
    RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.

Первичные конечные точки

  • Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn) [Срок оценки: 24 months]
  • Diagnosis of Parkinson's disease (PD) or dementia [Срок оценки: 8 years]
Вторичные конечные точки (10)
  • Smell test [Срок оценки: 24 months]
  • Smell test [Срок оценки: 24 months]
  • Motor function [Срок оценки: 24 months]
  • Dysautonomia and non-motor symptoms [Срок оценки: 24 months]
  • Subjective motor symptoms [Срок оценки: 24 months]
  • Cognition [Срок оценки: 24 months]
  • Prodromal PD [Срок оценки: 24 months]
  • REM-sleep [Срок оценки: Ever]
  • Color vision [Срок оценки: Now]
  • Co-morbidities and medication [Срок оценки: 10 years]

Критерии участия

Inclusion criteria with patients iOD:

  • Age 55 -75 years of age
  • Slowly progressing and non-fluctuating iOD
  • Able to give informed consent and to cooperate as evaluated by the PI

Exclusion criteria with patients iOD:

  • Diagnosed with a neurodegenerative disease or major neurological/psychiatric condition.
  • Anosmia/hyposmia caused by sino-nasal disease (including chronic rhinitis and allergy), after trauma, infection, congenial, olfactory dysfunction due to surgery, or toxins/drugs affecting the olfactory function.
  • Olfactory dysfunction with response to systemic or local corticosteroids if tried
  • Severe nasal cavity abnormalities or infections.
  • Overt signs of dementia or PD
  • Current alcohol or drug abuse
  • Terminal illness
  • Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.

Inclusion criteria controls:

  • Age 55 -75 years of age
  • Able to give informed consent
  • Able to cooperate as evaluated by the PI

Exclusion criteria controls:

  • Olfactory dysfunction on clinical test
  • Overt signs of dementia or PD
  • Severe nasal cavity abnormalities or infections.
  • Current alcohol or drug abuse
  • Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.

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

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Дания · 2 центра
  • Danish Dementia Research Centre — Copenhagen
  • Oskar McWilliam — Copenhagen

Идентификаторы

NCT: NCT05740683 · H-22053428

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗