Health Trials

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

ConditionsAlzheimer DiseaseInsomnia DisorderSleep
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

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

Treatments tested in this trial

  • Daridorexant 50 mg
  • Placebo
  • Polysomnography
  • Neuropsychological assessment
  • Questionnaires on sleep and behavioural problems
  • Actimetrics
  • 24-hour Ambulatory Blood Pressure Monitoring (ABPM
  • Biomarker assay

Treatment groups

62 Participants
are divided into 2 treatment groups

Locations

1
University Hospital, Montpellier Montpellier France

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Collaborator

Source ClinicalTrials.gov