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New treatment option for Postoperative Cognitive Decline
Official title Daridorexant to Prevent Post-cardiotomy Delirium
ClinicalTrials.gov ID: NCT07217912
What this study is testing
What is Daridorexant 50 mg?
Daridorexant 50 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for postoperative cognitive decline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in...
- family member or close friend for collateral.
You likely can't join if
- Prior cardiotomy
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline (positive 3D-CAM)
- Auditory or visual impairment that prevents study procedures
- Alcohol or substance misuse (CAGE-AID score ≥ 2)
See the full eligibility criteria
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- family member or close friend for collateral.
- Prior cardiotomy
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline (positive 3D-CAM)
- Auditory or visual impairment that prevents study procedures
- Alcohol or substance misuse (CAGE-AID score ≥ 2)
- Psychotic disorder
- Dementia-level deficits (TICS \< 27)
- Use of a prescription sleep aid at least every other night
- Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)
- Daridorexant intolerance
- Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \<30 mL/min, or on dialysis)
- Narcolepsy
- Suicidal ideation at baseline
- Any condition that, in the PI's opinion, compromises patient safety or data quality
- Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.