Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

Официальное название

Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?

Обзор

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD. Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.

Вмешательства

• Процедура Polysomnography
  Polysomnography will be performed for 24 hours at inclusion and 24 months
• Поведенческое Neuropsychological assessment
  A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
• Поведенческое Questionnaires on sleep and behavioural problems
  Questionnaires on sleep and behavioural problems
• Процедура Actimetrics
  Measurement of actimetrics for 14 days at inclusion and at 24 months
• Другое Biomarker assay
  Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid

Первичные конечные точки

• Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score [Срок оценки: From inclusion to 24 months]

Вторичные конечные точки (8)

• Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score [Срок оценки: From inclusion to 12 months]
• Cognitive decline in ADCS-PACC composite score [Срок оценки: At inclusion and at 12 months]
• Concentration of proteins involved in Alzheimer disease [Срок оценки: At inclusion and at 24 months]
• Sleep time at stage 1-2 during polysomnography [Срок оценки: At inclusion and at 24 months]
• Sleep time at stage 3 during polysomnography [Срок оценки: At inclusion and at 24 months]
• Time spent in Rapide Eye Movement (REM) sleep during polysomnography [Срок оценки: At inclusion and at 24 months]
• Apnea Hypopnea index [Срок оценки: At inclusion and at 24 months]
• Noctural oxygene saturation (SaO2) [Срок оценки: At inclusion and at 24 months]

Критерии участия

Критерии включения

• Diagnosis of mild Alzheimer's disease with a MMS between 21-30
• Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
• No antidepressant or anxiolytic treatment or stopped for at least 15 days
• The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
• Signed informed consent
• Able to carry out all visits and follow study procedures
• Affiliation to the French social security system

Критерии исключения

• Genetic form of alzheimer's disease
• Insufficient clinical and paraclinical information for the diagnosis of AD
• Patient living in a nursing home
• Illiteracy or inability to perform psycho-behavioural tests
• Major physical or neurosensory problems that may interfere with the tests
• Patient deprived of liberty, by judicial or administrative decision;
• Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Major protected by law;
• Short-term life-threatening conditions

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

Диагностика

Центры проведения

Франция · 1 центр

• CHU de Montpellier — Montpellier

Идентификаторы

NCT: NCT05649514 · RECHMPL22_0392

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗