NCT05924425Toboroz4. fázis
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 25.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 62 (tervezett)
- Első benyújtás
- 2023. jún. 4.
- Kezdés
- 2024. márc. 13.
- Elsődleges befejezés
- 2027. máj. 13.
- Fő szponzor
- University Hospital, Montpellier
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT05924425
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 62
- 2024. márc. 13. és az elsődleges befejezés (2027. máj. 13.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Kiket keres a vizsgálat
- Age [60-85] years old
- Outpatients
- Pre-screening:
- 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
- Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening
- Baseline PSG (at randomization) assessed TST < 6 hours and WASO > 1 hour
- Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and/or positive plasma biomarker, and neuronal injury (hippocampal and/or temporal atrophy by MRI))
- MMSE from 12 to 26
- Clinical Dementia Rating CDR from 0.5 to 2
- Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).
- For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed
- Non inclusion criteria :
- Patients significantly dependent on caregivers
- Institutionalized patients
- Analphabetism or subjects unable to read or/and write
- Patients unable to perform the neuropsychological tests
- Patients unable to complete the study instruments (sleep diary)
- Planned longer stay outside the region that prevents compliance with the visit schedule
- Patients who cannot be followed up for at least 2 months
- History of narcolepsy and/or cataplexy
- History of drug or alcohol abuse or addiction
- History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry
- Moderate and severe liver failure
- PSG baseline evidence of significant/severe sleep-related breathing disorder (defined as >30 apnea/hypopnea episodes per hour)
- Treatments interfering with sleep-wake patterns
- Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)
- Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)
- Forbidden and restricted concomitant medications:
- Concomitant CNS-depressant medicinal products
- CYP3A4 inhibitors
- CYP3A4 inducers
- Participation in another clinical trial or administration of an investigational product
- Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship).
- Subjects not covered by public health insurance
- Failure to obtain written informed consent after a reflection period
Életkor a regiszterben: 60 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospital, Montpellier | Montpellier | Franciaország | Toboroz |
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