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

NARecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

April 17, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2027

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

Trial Locations (3)

Unknown

RECRUITING

University Hospital, Montpellier, Montpellier

NOT_YET_RECRUITING

University Hospital of Poitiers, Poitiers

NOT_YET_RECRUITING

University Hospital of Toulouse, Toulouse

All Listed Sponsors
collaborator

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

OTHER_GOV

lead

University Hospital, Montpellier

OTHER