Actively Recruiting

Age: 18Years +
All Genders
NCT05234866

Paradoxical Lucidity in Severe End-Stage Dementia

Led by NYU Langone Health · Updated on 2025-08-14

520

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Paradoxical Lucidity in Severe End-Stage Dementia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

S

Sam Parnia, MD, PhD

CONTACT

N

Natalia Leontovich

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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