Paradoxical Lucidity in Severe End-Stage Dementia
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
Sponsor: NYU Langone Health · Participants: 520 · Started: Jun 2, 2022
Contact the study team
- Sam Parnia, MD, PhD · Phone: (646)-501-6923
- Natalia Leontovich · Phone: 917-227-0932
Official record on ClinicalTrials.gov — NCT05234866
Locations in the U.S.
| New York | NYU Langone Health, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.