DementiaNCT05234866
Paradoxical Lucidity in Severe End-Stage Dementia
An observational study of Dementia, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Sam Parnia, MD, PhD
About this study
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.
- Conditions
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase I (Feasibility Study) | Not described | |
| Phase II (Prospective Study) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to Day 7
Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.
Measured: up to Day 7
Phase I - Number of families who express interest in the study and contact the research team
Measured: up to Day 7
Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies
Measured: up to Day 7
Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days
Measured: up to Day 7
Phase I - Number of diary reports completed and returned to research staff
Measured: up to Day 7
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
Measured: up to Day 7
Phase I - Total number of instances in which video EEG monitoring was successfully initiated
Measured: up to Day 7
Phase I - Average number of days for which video EEG monitoring was completed
Measured: up to Day 7
Secondary outcomes (2)
Phase II - Change in average number of changes in EEG rhythm
Measured: Baseline, up to Day 7
Phase II - Average number of changes in EEG rhythm during PL
Measured: Baseline, up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start2 Jun 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sam Parnia, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234866
- Sponsor's protocol ID
- 20-01854
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paradoxical Lucidity in Severe End-Stage Dementia
- ClinicalTrials.gov ID
- NCT05234866
- Acronym / sponsor ID
- 20-01854
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I (Feasibility Study) | – | – |
| Phase II (Prospective Study) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.
Time frame: up to Day 7
Phase I - Number of families who express interest in the study and contact the research team
Time frame: up to Day 7
Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies
Time frame: up to Day 7
Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days
Time frame: up to Day 7
Phase I - Number of diary reports completed and returned to research staff
Time frame: up to Day 7
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
Time frame: up to Day 7
Phase I - Total number of instances in which video EEG monitoring was successfully initiated
Time frame: up to Day 7
Phase I - Average number of days for which video EEG monitoring was completed
Time frame: up to Day 7
2 secondary outcomes
Phase II - Change in average number of changes in EEG rhythm
Time frame: Baseline, up to Day 7
Phase II - Average number of changes in EEG rhythm during PL
Time frame: Baseline, up to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Dementia
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Parnia, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam Parnia, MD, PhD ((646)-501-6923, Sam.Parnia@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.