Paradoxical Lucidity in Severe End-Stage Dementia

Overview

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.

Primary outcome 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 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]

Secondary outcome measures (2)

• Phase II - Change in average number of changes in EEG rhythm [Time frame: Baseline, up to Day 7]
• Phase II - Average number of changes in EEG rhythm during PL [Time frame: Baseline, up to Day 7]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT05234866 · 20-01854

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗