Paradoxical Lucidity in Severe End-Stage Dementia

Dementia Clinical Trial

Official title:

Paradoxical Lucidity in Severe End-Stage Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234866
• Other study ID #: 20-01854
• Status: Recruiting
• Start date: June 2, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Sam Parnia, MD, PhD
• Phone: (646)-501-6923
• Email: Sam.Parnia[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: May 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		up to Day 7
Primary	Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.		up to Day 7
Primary	Phase I - Number of families who express interest in the study and contact the research team		up to Day 7
Primary	Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies		up to Day 7
Primary	Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days		up to Day 7
Primary	Phase I - Number of diary reports completed and returned to research staff		up to Day 7
Primary	Phase I - Time taken to establish video EEG monitoring in homes or nursing homes		up to Day 7
Primary	Phase I - Total number of instances in which video EEG monitoring was successfully initiated		up to Day 7
Primary	Phase I - Average number of days for which video EEG monitoring was completed		up to Day 7
Secondary	Phase II - Change in average number of changes in EEG rhythm		Baseline, up to Day 7
Secondary	Phase II - Average number of changes in EEG rhythm during PL		Baseline, up to Day 7