Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline? (ALZ-OREX)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Neuropathology

Treatments: Behavioral: Questionnaires on sleep and behavioural problems; Procedure: Actimetry; Procedure: Polysomnography; Behavioral: Neuropsychological assessment; Procedure: Internal temperature measurement; Diagnostic Test: Fractional diuresis; Other: Biomarker assay

Study type: Interventional

Funder types: Other

Identifiers

NCT05629871

RECHMPL18_0061

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30
• The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
• Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes
• Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care
• Signed informed consent
• Able to carry out all visits and follow study procedures
• Affiliation to the French social security system

Exclusion criteria

• Genetic form of alzheimer's disease
• Insufficient clinical and paraclinical information for the diagnosis of AD
• Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
• Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion
• 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
• Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
• Refusal to perform a diagnostic lumbar puncture
• Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders
• Patient deprived of liberty, by judicial or administrative decision;
• Major protected by law;
• Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached;
• Refusal to participate in the protocol.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Single arm

Experimental group

Description:

Alzheimer

Treatment:

Other: Biomarker assay

Diagnostic Test: Fractional diuresis

Procedure: Internal temperature measurement

Behavioral: Neuropsychological assessment

Procedure: Actimetry

Behavioral: Questionnaires on sleep and behavioural problems

Procedure: Polysomnography