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Observational Study of Paradoxical Lucidity in Severe End-Stage Dementia

This study is looking into "paradoxical lucidity" (PL), which are unexpected moments of clarity that some people with severe dementia experience. While cognitive decline in dementia is usually seen as permanent, these brief episodes suggest there might be other things happening in the brain. Currently, we don't know much about PL beyond personal stories. This study aims to define what PL is, create a way to measure it, and identify any brain signals (electrocortical biomarkers) linked to these moments in people with advanced dementia. You could be eligible if you are over 18, have severe dementia (Global Deterioration Scale score of 7 or Palliative Performance Scale score less than 30%), are in hospice care, and are no longer receiving nutrition or fluids.

Study design
This is an observational study, meaning researchers will watch and record information without giving any specific treatments. It plans to enroll 520 participants and is divided into two phases.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track self-reports of patient distress/discomfort and potential PL episodes for up to 7 days. Informant distress related to video EEG devices will also be measured for up to 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05234866

Paradoxical Lucidity in Severe End-Stage Dementia

Recruiting
Not specifiedAges 18+Observational
NYU Langone Health
~520 participants
Updated 2026-07-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I and II - Number of self-reports of patient distress/discomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devices
Measured over up to Day 7
+8 more outcomes measured

Conditions

Dementia

Explore related trials

Dementia

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Sam Parnia, MD, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Sam Parnia, MD, PhD
[email protected]
(646)-501-6923
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 18 years
Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%
Accepted for hospice care based on the Medicare eligibility guidelines
No longer being provided with nutrition or fluids
Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period

Exclusion

Cognitive or functional impairment due to a diagnosis other than dementia

What this trial measures

  • Phase I and II - Number of self-reports of patient distress/discomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devicesup to Day 7
  • Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.up to Day 7
  • Phase I - Number of families who express interest in the study and contact the research teamup to Day 7
  • Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxiesup to Day 7
  • Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 daysup to Day 7
  • Phase I - Number of diary reports completed and returned to research staffup to Day 7
  • Phase I - Time taken to establish video EEG monitoring in homes or nursing homesup to Day 7
  • Phase I - Total number of instances in which video EEG monitoring was successfully initiatedup to Day 7
  • Phase I - Average number of days for which video EEG monitoring was completedup to Day 7