EICHORCondition: Dementia · Sponsor: NYU Langone Health
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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.
This description comes directly from the study's public registry record.
Sam Parnia, MD, PhD · (646)-501-6923 · Sam.Parnia@nyulangone.org
Natalia Leontovich · 917-227-0932 · pl@nyulangone.org
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| NYU Langone Health | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05234866