Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT05234866

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia.

Conditions

Dementia

Study ID

NCT05234866

Start date

Jun 2, 2022

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Cognitive or functional impairment due to a diagnosis other than dementia
  • Dementia with a GDS score <7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.

Study Design

Enrollment

520 participants

Anticipated

Interventions and Outcome Measures

Arms

Phase I (Feasibility Study)

Phase II (Prospective Study)

Primary outcome measure

  • 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 [ Time Frame: up to Day 7 ]
  • Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device. [ Time Frame: up to Day 7 ]
  • Phase I - Number of families who express interest in the study and contact the research team [ Time Frame: up to Day 7 ]
  • Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies [ Time Frame: up to Day 7 ]
  • Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days [ Time Frame: up to Day 7 ]
  • Phase I - Number of diary reports completed and returned to research staff [ Time Frame: up to Day 7 ]
  • Phase I - Time taken to establish video EEG monitoring in homes or nursing homes [ Time Frame: up to Day 7 ]
  • Phase I - Total number of instances in which video EEG monitoring was successfully initiated [ Time Frame: up to Day 7 ]
  • Phase I - Average number of days for which video EEG monitoring was completed [ Time Frame: up to Day 7 ]

Central Contacts and Locations

Central contacts

Sam Parnia, MD, PhD

(646)-501-6923Sam.Parnia@nyulangone.org

Natalia Leontovich

917-227-0932pl@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Sam Parnia, MD, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-10.