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

Sponsor
University Hospital, Montpellier
Study ID
NCT05924425
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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
    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
    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
    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

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
Mar 2026
Primary completion
May 13, 2027
Completion
Mar 13, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Daridorexant 50 mg
    Patients will receive daridorexant 50 mg during one month (Period A or Period B). Daridorexant is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia.
  • Placebo Comparator: Placebo-controlled arm
    Patients will receive a placebo matching to daridorexant 50 mg during one month (Period A or Period B).

Primary Outcome Measure

Change in Total Sleep Time (TST). [ Time Frame: from baseline to the end of each period A/B (Month1/Month2) ]

Central Contacts

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