Daridorexant to Prevent Delirium After Heart Surgery

NCT06630390 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00009841
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events. Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.

Conditions

POSTOPERATIVE DELIRIUM; POSTOPERATIVE COGNITIVE DECLINE

Keywords

delirium; sleep; cognitive decline; Alzheimer disease and related dementias

Outcome Measures

Primary Outcomes (1)

• Delirium

  In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.

  First 3 days after surgery

Secondary Outcomes (1)

• Sleep Disturbance

  First 3 days after surgery

Study Arms (2)

Daridorexant

EXPERIMENTAL

Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.

Drug: Daridorexant 50 mg

Placebo

PLACEBO COMPARATOR

Oral matching placebo each of the first three nights after heart surgery.

Other: Placebo

Interventions

Daridorexant 50 mg DRUG

Administered consistent with labeling from the US Food and Drug Administration.

Daridorexant

Placebo OTHER

Identical appearing to daridorexant

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
• Can provide informed consent
• Able to speak, read, and write English
• Family member or close friend available for collateral

You may not qualify if:

• Prior heart surgery
• Infectious endocarditis
• Emergency surgery
• Delirium at baseline
• Auditory/visual impairment preventing study procedures
• Active alcohol or substance misuse
• Psychotic disorder
• Dementia-level deficits
• Use of a sleep aid before surgery
• Use of a strong 3A4 inhibitor
• Intolerance to daridorexant
• Severe kidney or liver impairment
• Narcolepsy
• Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Delirium; Cognitive Dysfunction; Alzheimer Disease

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Mark Oldham
• Organization: University of Rochester Medical Center

mark_oldham@urmc.rochester.edu

585-275-3592

Study Officials

• Mark A Oldham, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Participants will be randomized to either the daridorexant or placebo arm.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: November 11, 2024
• Primary Completion: February 16, 2025
• Study Completion: February 16, 2025
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)