Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
Study NCT ID:
NCT05234866
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2022-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paradoxical Lucidity in Severe End-Stage Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'up to Day 7'}, {'measure': "Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.", 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Number of families who express interest in the study and contact the research team', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Number of diary reports completed and returned to research staff', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Time taken to establish video EEG monitoring in homes or nursing homes', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Total number of instances in which video EEG monitoring was successfully initiated', 'timeFrame': 'up to Day 7'}, {'measure': 'Phase I - Average number of days for which video EEG monitoring was completed', 'timeFrame': 'up to Day 7'}], 'secondaryOutcomes': [{'measure': 'Phase II - Change in average number of changes in EEG rhythm', 'timeFrame': 'Baseline, up to Day 7'}, {'measure': 'Phase II - Average number of changes in EEG rhythm during PL', 'timeFrame': 'Baseline, up to Day 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Adults over 18 years of age diagnosed with advanced dementia\n2. Hospice workers, geriatric, palliative care physicians and other healthcare providers\n3. Family, friends and caregivers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* 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%\n* Accepted for hospice care based on the Medicare eligibility guidelines\n* No longer being provided with nutrition or fluids\n* Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period\n\nExclusion Criteria:\n\n* Cognitive or functional impairment due to a diagnosis other than dementia\n* Dementia with a GDS score \\<7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.'}, 'identificationModule': {'nctId': 'NCT05234866', 'briefTitle': 'Paradoxical Lucidity in Severe End-Stage Dementia', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Paradoxical Lucidity in Severe End-Stage Dementia', 'orgStudyIdInfo': {'id': '20-01854'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase I (Feasibility Study)'}, {'label': 'Phase II (Prospective Study)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sam Parnia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Sam Parnia, MD, PhD', 'role': 'CONTACT', 'email': 'Sam.Parnia@nyulangone.org', 'phone': '(646)-501-6923'}, {'name': 'Natalia Leontovich', 'role': 'CONTACT', 'email': 'pl@nyulangone.org', 'phone': '917-227-0932'}], 'overallOfficials': [{'name': 'Sam Parnia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.', 'accessCriteria': 'The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a date access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}