Clinical trial NCT05234866: Paradoxical Lucidity in Severe End-Stage Dementia
Official title: Paradoxical Lucidity in Severe End-Stage Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-02-10
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Adults over 18 years of age diagnosed with advanced dementia
2. Hospice workers, geriatric, palliative care physicians and other healthcare providers
3. Family, friends and caregivers

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.


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.

Primary outcomes:
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
timeFrame: up to Day 7
measure: Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.
timeFrame: up to Day 7
measure: Phase I - Number of families who express interest in the study and contact the research team
timeFrame: up to Day 7
measure: Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies
timeFrame: up to Day 7
measure: Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days
timeFrame: up to Day 7
measure: Phase I - Number of diary reports completed and returned to research staff
timeFrame: up to Day 7
measure: Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
timeFrame: up to Day 7
measure: Phase I - Total number of instances in which video EEG monitoring was successfully initiated
timeFrame: up to Day 7
measure: Phase I - Average number of days for which video EEG monitoring was completed
timeFrame: up to Day 7
Secondary outcomes:
measure: Phase II - Change in average number of changes in EEG rhythm
timeFrame: Baseline, up to Day 7
measure: Phase II - Average number of changes in EEG rhythm during PL
timeFrame: Baseline, up to Day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sam Parnia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: