Study: NCT05924425

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daridorexant 50 mg
Description: Patients randomized in the experimental group will receive the treatment every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients randomized in the control group will receive the placebo every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Polysomnography
Description: A full-night polysomnography recording with blood pressure and heart rate monitoring will be performed at night in the Sleep Laboratory from 11 p.m. to 7 a.m. at baseline (before the randomization) and at the end of each period (Period A/M1, Period B/M2). The recording procedure consists of an electroencephalogram, two electrooculograms, an electromyogram, an electrocardiogram, and a videographic recording. This examination is painless (the sensors are glued to the skin for the duration of the recording). The advantages of this video-polysomnography are based on the evaluation of sleep architecture, micro-arousals, respiratory events and nocturnal motor behavior.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Polysomnography
Description: A full-night polysomnography recording with blood pressure and heart rate monitoring will be performed at night in the Sleep Laboratory from 11 p.m. to 7 a.m. at baseline (before the randomization) and at the end of each period (Period A/M1, Period B/M2). The recording procedure consists of an electroencephalogram, two electrooculograms, an electromyogram, an electrocardiogram, and a videographic recording. This examination is painless (the sensors are glued to the skin for the duration of the recording). The advantages of this video-polysomnography are based on the evaluation of sleep architecture, micro-arousals, respiratory events and nocturnal motor behavior.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Neuropsychological assessment
Description: A full neuropsychological assessment will be performed at inclusion, M1, M2

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Neuropsychological assessment
Description: A full neuropsychological assessment will be performed at inclusion, M1, M2

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaires on sleep and behavioural problems
Description: Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Questionnaires on sleep and behavioural problems
Description: Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Actimetrics
Description: Measurement of actimetrics for seven days in average (with a minimum of three nights required) prior to the inclusion visit, M1 visit and M2 visit.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Actimetrics
Description: Measurement of actimetrics for seven days in average (with a minimum of three nights required) prior to the inclusion visit, M1 visit and M2 visit.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 24-hour Ambulatory Blood Pressure Monitoring (ABPM
Description: Evaluation of the 24-hour hemodynamic profile of a patient by multiple and regular blood pressure and heart rate measurements. The ABP will be monitored at inclusion, M1 and M2

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: 24-hour Ambulatory Blood Pressure Monitoring (ABPM
Description: Evaluation of the 24-hour hemodynamic profile of a patient by multiple and regular blood pressure and heart rate measurements. The ABP will be monitored at inclusion, M1 and M2

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Biomarker assay
Description: Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) in serum and cerebrospinal fluid (CSF) and dosage of Orexin-A/hypocretin-1 in the CSF

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Biomarker assay
Description: Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) in serum and cerebrospinal fluid (CSF) and dosage of Orexin-A/hypocretin-1 in the CSF