AzTrials
AzTrials

NeuropathologyALZ-OREXNCT05629871

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

A study testing Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems in people with Neuropathology, run by University Hospital, Montpellier at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Neuropathology
What is being tested?
Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
3 sitesFrance
Study dates
17 Apr 2023to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Claire Denis contact

+33467333162

claire-denis@chu-montpellier.fr

Yves Dauvilliers, MD contact

+33467335219

y-dauvilliers@chu-montpellier.fr

France3 sites, 3 recruiting

  • University Hospital, Montpellier

    Montpellier

    Karim BENNYS, MD

    Karim BENNYS, MD

    Recruiting

  • University Hospital of Poitiers

    Poitiers

    Marc PACCALIN, MD

    Marc PACCALIN

    Not yet recruiting

  • University Hospital of Toulouse

    Toulouse

    Rachel DEBS, MD

    Rachel DEBS, MD

    Not yet recruiting

Other trials in France

About this study

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.

Conditions
Neuropathology
Being tested
Polysomnography, Neuropsychological assessment, Questionnaires on sleep and behavioural problems, Actimetry, Fractional diuresis
Keywords
cognitive composite score, sleep, biomarkers, cognitive decline
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolysomnographyProcedure or surgery

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

  • Neuropsychological assessmentBehavioural

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

  • Questionnaires on sleep and behavioural problemsBehavioural

    Questionnaires on sleep and behavioural problems

  • ActimetryProcedure or surgery

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

  • Fractional diuresisDiagnostic 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 measurementProcedure or surgery

    eCelsius capsule to measure internal temperature at inclusion and 24 months

  • Biomarker assayOther

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

Study groups in NCT05629871
Study groupRoleWhat they receive
Single armExperimentalAlzheimer
Receives: Procedure: Polysomnography; Behavioral: Neuropsychological assessment; Behavioral: Questionnaires on sleep and behavioural problems; Procedure: Actimetry; Diagnostic Test: Fractional diuresis; Procedure: Internal temperature measurement; Other: Biomarker assay

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: From inclusion to 24 months

Secondary outcomes (13)

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

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

    Measured: From inclusion to 12 months

  2. Cognitive decline in ADCS-PACC composite score

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

    Measured: At inclusion and at 24 months

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

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

    Measured: At inclusion and at 12 months

  4. Concentration of proteins involved in Alzheimer disease

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

    Measured: At inclusion and at 24 months

  5. Concentration of orexinA/hypocretin

    Determination in serum and cerebrospinal fluid

    Measured: At inclusion and at 24 months

  6. Changes in sleep duration

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

    Measured: At inclusion and at 24 months

  7. Sleep time at stage 1-2 during polysomnography

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

    Measured: At inclusion and at 24 months

  8. Sleep time at stage 3 during polysomnography

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

    Measured: At inclusion and at 24 months

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

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

    Measured: At inclusion and at 24 months

  10. Apnea Hypopnea Index

    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

    Measured: At inclusion and at 24 months

  11. Nocturnal oxygen saturation (SaO2)

    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

    Measured: At inclusion and at 24 months

  12. Urinary melatonin concentration

    Fractional diuresis

    Measured: At inclusion and at 24 months

  13. Internal temperature

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

    Measured: At inclusion and at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start17 Apr 2023
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05629871
Sponsor's protocol ID
RECHMPL18_0061
Acronym
ALZ-OREX
Status last verified
Sep 2025
First submitted
28 Oct 2022
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems in people with Neuropathology, run by University Hospital, Montpellier at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire Denis (+33467333162, claire-denis@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Free and Cued Selective Reminding Test (FCSRT) scale score (time frame: From inclusion to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05629871.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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