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

NCT05629871 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-10-07

No results posted yet for this study

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. 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

Interventions

PROCEDURE

Polysomnography

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

BEHAVIORAL

Neuropsychological assessment

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

BEHAVIORAL

Questionnaires on sleep and behavioural problems

Questionnaires on sleep and behavioural problems

PROCEDURE

Actimetry

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

DIAGNOSTIC_TEST

Fractional diuresis

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

PROCEDURE

Internal temperature measurement

eCelsius capsule to measure internal temperature at inclusion and 24 months

OTHER

Biomarker assay

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

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Karim BENNYS, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629871 on ClinicalTrials.gov