Actively Recruiting

Phase 4
Age: 60Years - 85Years
All Genders
NCT05924425

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

Led by University Hospital, Montpellier · Updated on 2026-04-23

62

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Montpellier

Lead Sponsor

I

Idorsia Pharmaceuticals Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 60 and 85 years old
  • Outpatient status
  • Complaints of poor sleep quantity or quality at least 3 nights per week for at least 3 months
  • Total sleep time below 6 hours on at least 3 nights per week for at least 1 month before screening
  • Baseline polysomnography showing total sleep time less than 6 hours and wake after sleep onset more than 1 hour
  • Diagnosis of mild cognitive impairment or mild to moderate Alzheimer's disease based on clinical criteria and biomarkers
  • Mini-Mental State Examination (MMSE) score between 12 and 26
  • Clinical Dementia Rating (CDR) between 0.5 and 2
  • Stable dose of certain central nervous system drugs for at least 3 months if used (anticholinesterase drugs or memantine)
  • No contraceptive methods needed for sexually active males who are not sterilized with partners of childbearing potential
Not Eligible

You will not qualify if you...

  • Significant dependence on caregivers
  • Institutionalized patients
  • Illiteracy or inability to read and write
  • Inability to perform neuropsychological tests
  • Inability to complete study instruments such as sleep diary
  • Planned extended stay outside the region that prevents visit compliance
  • Unable to be followed up for at least 2 months
  • History of narcolepsy or cataplexy
  • History of drug or alcohol abuse or addiction
  • History of depression, suicidal ideation or attempt, or other psychiatric conditions
  • Moderate to severe liver failure
  • Polysomnography evidence of severe sleep-related breathing disorder (more than 30 apnea/hypopnea episodes per hour)
  • Use of treatments interfering with sleep-wake patterns including psychotropic drugs (certain antidepressants, neuroleptics, hypnotics) or level 2 or 3 pain drugs
  • Hypersensitivity to daridorexant or its excipients
  • Use of certain forbidden medications including CNS-depressants, CYP3A4 inhibitors or inducers
  • Participation in another clinical trial or use of investigational products
  • Protected populations such as those under legal protection, prisoners, pregnant or breastfeeding women, or under guardianship
  • Not covered by public health insurance
  • Failure to provide written informed consent after reflection period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital, Montpellier

Montpellier, France

Actively Recruiting

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Research Team

Y

Yves Dauvilliers, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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