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NCT Number: NCT05629871

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

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.

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Key information

Conditions

Neuropathology Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Montpellier, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnography

Procedure

Polysomnography will be performed for 24 hours at inclusion and 24 months

Neuropsychological Assessment

Behavioral

A full neuropsychological assessment will be performed at inclusion, 12 and 24 months

Questionnaires on sleep and behavioural problems

Behavioral

Questionnaires on sleep and behavioural problems

Actimetry

Procedure

Measurement of actimetrics for 14 days at inclusion and at 24 months

Fractional diuresis

Diagnostic Test

Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration

Internal temperature measurement

Procedure

eCelsius capsule to measure internal temperature at inclusion and 24 months

Biomarker assay

Other

Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid

Primary outcomes

  1. Change in the Free and Cued Selective Reminding Test (FCSRT) scale score

    Time frame: From inclusion to 24 months

    The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome

Secondary outcomes

  1. Change in the Free and Cued Selective Reminding Test (FCSRT) scale score

    Time frame: From inclusion to 12 months

    The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome

  2. Cognitive decline in ADCS-PACC composite score

    Time frame: At inclusion and at 24 months

    The ADCS-PACC composite score is used to assess cognitive decline

  3. Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score

    Time frame: At inclusion and at 12 months

    The ADCS-PACC composite score is used to assess cognitive decline

  4. Concentration of proteins involved in Alzheimer disease

    Time frame: At inclusion and at 24 months

    Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid

  5. Concentration of orexinA/hypocretin

    Time frame: At inclusion and at 24 months

    Determination in serum and cerebrospinal fluid

  6. Changes in sleep duration

    Time frame: At inclusion and at 24 months

    Average sleep duration (in hours and minutes) over a 14-day period from inclusion to M24 measured by actimetry

  7. Sleep time at stage 1-2 during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography

  8. Sleep time at stage 3 during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in stage 3 sleep measured in hours and minutes during polysomnography

  9. Time spent in Rapid eye movement (REM) sleep during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in stage 3 sleep measured in hours and minutes during polysomnography

  10. Apnea Hypopnea Index

    Time frame: At inclusion and at 24 months

    The Apnea-Hypopnea Index is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hypopneas / number of hours of sleep) during polysomnography

  11. Nocturnal oxygen saturation (SaO2)

    Time frame: At inclusion and at 24 months

    The nocturnal SaO2 is an average of SaO2 values taken during the night. The value is expressed as a percentage and is measured during polysomnography

  12. Urinary melatonin concentration

    Time frame: At inclusion and at 24 months

    Fractional diuresis

  13. Internal temperature

    Time frame: At inclusion and at 24 months

    The internal temperature will be measured with an e-Celsius capsule during polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Denis

CONTACT

[email protected]

+33467333162

Yves Dauvilliers, MD

CONTACT

[email protected]

+33467335219

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: ALZ-OREX

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 29, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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