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RECRUITING
NCT05629871
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-04-17

Completion Date

2027-07-01

Last Updated

2025-10-07

Healthy Volunteers

No

Conditions

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

Locations (3)

University Hospital, Montpellier

Montpellier, France

University Hospital of Poitiers

Poitiers, France

University Hospital of Toulouse

Toulouse, France