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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Polysomnography

    Procedure/Surgery

    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/Surgery

    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/Surgery

    eCelsius capsule to measure internal temperature at inclusion and 24 months

  • Biomarker assay

    Other intervention

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

Treatment groups

132 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

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

Time frame
From inclusion to 24 months

Secondary outcomes

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

Time frame
From inclusion to 12 months
2

Cognitive decline in ADCS-PACC composite score

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

Time frame
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

Time frame
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

Time frame
At inclusion and at 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

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

Collaborator