Phase 2 Alzheimer's Disease Trial, Recruiting NCT07217912 Sponsor: University of Rochester Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT07217912
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 60 years or older
  • People who are scheduled to have heart valve surgery (surgical aortic valve surgery) or heart bypass surgery (coronary artery bypass graft) at Strong Memorial Hospital
  • People who are able to give their own consent to take part
  • People who can speak, read, and write in English, as the study tools and interviews used have only been validated in English
  • People who have a family member or close friend who can provide additional information about them as part of the study

Who may not be able to join:

  • People who have had previous open-heart surgery
  • People who have an infection of the heart valves (infective endocarditis)
  • People who need emergency surgery
  • People who show signs of delirium (sudden confusion) at the start of the study, based on a specific screening test (3D-CAM)
  • People who have hearing or vision problems that would prevent them from taking part in study activities
  • People who score 2 or higher on a screening tool for alcohol or drug misuse (CAGE-AID)
  • People who have a psychotic disorder
  • People whose memory and thinking scores fall below a certain level on a screening test (TICS score below 27), suggesting dementia-level difficulties
  • People who use a prescription sleep aid at least every other night
  • People who regularly take certain medications that strongly affect how the body processes drugs — these are known as strong CYP3A4 inhibitors (examples include clarithromycin, ketoconazole, itraconazole, ritonavir, and several others — confirm with trial site if unsure whether a current medication is on this list)
  • People who have had a bad reaction or intolerance to a medication called daridorexant
  • People with severe kidney or liver disease, including those on dialysis (confirm with trial site regarding specific test thresholds)
  • People who have narcolepsy (a condition causing uncontrollable sleep episodes)
  • People who have thoughts of suicide at the start of the study
  • People whose participation, in the opinion of the lead researcher, could put their safety at risk or affect the quality of the study data
  • For one specific part of the study focused on language analysis: people with a history of traumatic brain injury or concussion with loss of consciousness, people currently using corticosteroid medications, or people with a history of major neurological disease or brain surgery

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 585-275-3592

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
14 October 2025
Est. completion
1 November 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Delirium incidence and severity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov