NCT05234866 Paradoxical Lucidity in Severe End-Stage Dementia
| NCT ID | NCT05234866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Dementia |
| Study Type | OBSERVATIONAL |
| Enrollment | 520 participants |
| Start Date | 2022-06-02 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 520 participants in total. It began in 2022-06-02 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Sam Parnia, MD, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05234866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05234866 currently recruiting?
Yes, NCT05234866 is actively recruiting participants. Contact the research team at Sam.Parnia@nyulangone.org for enrollment information.
Where is the NCT05234866 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05234866 clinical trial?
NCT05234866 is sponsored by NYU Langone Health. The principal investigator is Sam Parnia, MD, PhD at NYU Langone Health. The trial plans to enroll 520 participants.