Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

ConditionsAlzheimer Disease Insomnia Disorder Sleep

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age60-85

SponsorUniversity Hospital, Montpellier

About this trial

DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age [60-85] years old

Outpatients

Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and

Total sleep time causes clinically significant distress or impairment in daytime functioning, and

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

Daridorexant 50 mg
Drug
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.
Placebo
Drug
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.
Polysomnography
Procedure/Surgery
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.
Neuropsychological assessment
Behavioral
A full neuropsychological assessment will be performed at inclusion, M1, M2
Questionnaires on sleep and behavioural problems
Behavioral
Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2
Actimetrics
Procedure/Surgery
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.
24-hour Ambulatory Blood Pressure Monitoring (ABPM
Procedure/Surgery
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
Biomarker assay
Other intervention
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

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Daridorexant 50 mgExperimental treatment 7 interventions

Group B: Placebo-controlled armPlacebo comparator 7 interventions

Trial outcomes

Primary outcomes

Change in Total Sleep Time (TST).

TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. The TST is measured during polysomnography.

Time frame