Paradoxical Lucidity in Severe End-Stage Dementia

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05234866
Status
Recruiting
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Conditions

  • Dementia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 2, 2022
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
520 participants (estimated)

Arms

  • Arm: Phase I (Feasibility Study)
  • Arm: Phase II (Prospective Study)

Primary Outcome 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 [ Time Frame: up to Day 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Sam Parnia, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NY

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