Phase 2 Sleep Disorders Trial, Recruiting NCT07213349 Sponsor: Douglas Mental Health University Institute Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT07213349
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 whose memory and thinking test results fall above the threshold for dementia (as measured by standard cognitive tests, such as the MoCA, MMSE, or Clinical Dementia Rating scale)
  • People who have completed at least 6 years of formal schooling
  • People who have been on a stable dose of any psychiatric medications for at least 1 month before the screening visit, with no planned changes to that dose during the study
  • People who are able to read and sign a consent form in English or French

Who may not be able to join:

  • People who have a formal diagnosis of a major disorder affecting memory and thinking (such as dementia)
  • People with an unstable psychiatric condition
  • People with clinically significant active thoughts of suicide
  • People with an unstable medical condition, as determined by the trial investigator
  • People with a known or suspected history of drug or alcohol dependence or misuse within the past year
  • People who are currently taking a type of sleep medication called a DORA (dual orexin receptor antagonist) (confirm with trial site)
  • People who have a known allergy or serious adverse reaction to a DORA medication
  • People who have been using benzodiazepines or "z-drugs" (a type of sleep medication) more than twice a week in the past month
  • People who are taking certain medications that strongly affect how the liver processes drugs, known as major or moderate CYP3A4 inducers or inhibitors (confirm with trial site)
  • People who are taking strong medications that slow down the central nervous system, including opioid painkillers, strong analgesics, antipsychotics, or sedating antidepressants
  • People who are currently using medications called cholinesterase inhibitors or memantine (commonly used for dementia)
  • People who are pregnant or currently breastfeeding
  • People with severe obstructive sleep apnea (a condition where breathing repeatedly stops during sleep)
  • People with a clinically significant and untreated sleep disorder involving unusual movements or behaviours during sleep, restless leg syndrome, or other abnormal sleep behaviours
  • People who have been diagnosed with narcolepsy (a condition causing sudden and uncontrollable episodes of sleep)

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 19 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

Principal Investigator: Sylvia Villeneuve, PhD, McGill University

Phone: 855-888-4485

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
Sponsor
Douglas Mental Health University Institute
Registry
ClinicalTrials.gov
Start date
14 October 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Change in plasma p-tau217/np-tau217 ratio

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: 19 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