Exploring moments of clarity in severe dementia patients
Paradoxical Lucidity in Severe End-Stage Dementia
This study is trying to understand rare moments of clarity in people with severe dementia to see if there are patterns or signs in their brain activity that can help explain these episodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 520 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05234866 on ClinicalTrials.gov |
What this trial studies
This observational study investigates episodes of paradoxical lucidity in patients with severe end-stage dementia. It aims to develop a definition and measurement scale for these episodes while identifying potential electro cortical biomarkers associated with them. The study will be conducted in two phases, starting with data collection through online surveys and focus groups, followed by assessments using symptom diaries and real-time video EEG monitoring. The goal is to better understand the mechanisms behind these transient moments of clarity.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced dementia, specifically those diagnosed with a GDS score of 7 and accepted for hospice care.
Not a fit: Patients with cognitive impairment due to conditions other than dementia or those with less severe dementia (GDS score <7) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into cognitive functions in severe dementia, potentially improving care strategies.
How similar studies have performed: While episodes of paradoxical lucidity have been reported anecdotally, this study represents a novel approach to systematically investigate this phenomenon.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sam Parnia, MD, PhD — NYU Langone Health
- Study coordinator: Sam Parnia, MD, PhD
- Email: Sam.Parnia@nyulangone.org
- Phone: (646)-501-6923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.