Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2026-01-12 @ 2:12 PM
Study NCT ID:
NCT06467461
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phosphorylated alpha synuclein deposits on skin biopsy', 'timeFrame': 'time point 1 (baseline) and time point 2 (24 months, +/- 3 months)', 'description': 'Incidence (positive or negative) of phosphorylated alpha synuclein deposits. Indicating direct histopathological confirmation of underlying alpha-synuclein degeneration in 5-HT RBD in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD).'}, {'measure': 'Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex', 'timeFrame': 'time point 1 (baseline) and time point 2 (24 months, +/- 3 months)', 'description': 'Examination of the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures.'}, {'measure': 'Monopitch as measured by fundamental frequency variability.', 'timeFrame': 'time point 1 (baseline) and time point 2 (24 months, +/- 3 months)', 'description': "Participants' voice and speech quality will be examined for synucleinopathy syndrome. The focus on speech function is designed to detect subtle brainstem deficits prior to more overt manifestations of cortical dementia."}], 'secondaryOutcomes': [{'measure': 'Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.', 'timeFrame': 'time point 1 (baseline) and time point 2 (24 months, +/- 3 months)', 'description': 'Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.'}, {'measure': 'Speed of articulatory change as measured by F2 Transitions', 'timeFrame': 'time point 1 (baseline) and time point 2 (24 months, +/- 3 months)', 'description': 'Speed of articulatory change as measured by F2 Transitions, which are shown to be reduced in people with dysarthria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia With Lewy Bodies', 'Parkinson Disease', 'REM Sleep Behavior Disorder']}, 'descriptionModule': {'briefSummary': 'This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy.\n\nThe investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nInclusion Criteria:\n\n* Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.\n* History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants\n\nInclusion Criteria:\n\n* Age (±3 years) and sex matched to participants with 5-HT RBD\n* On serotonergic medication for at least 6 months without history of dream enactment.\n\nThe following serotonergic medications will be included:\n\nCitalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline\n\nExclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nExclusion Criteria:\n\n* Younger than 18\n* Older than 75\n* Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)\n* Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing\n* History of dysarthria, aphasia or other condition which could interfere with speech assessment\n* Reduced capacity to consent\n* MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, etc.).\n* History of allergic response to xylocaine or other local anesthesia\n* Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants\n\nExclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following:\n\n* History of dream enactment that may suggest RBD\n* Increased REM motor tone (REM atonia index \\> 0.10) on PSG suggestive of RBD"}, 'identificationModule': {'nctId': 'NCT06467461', 'briefTitle': 'Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder', 'orgStudyIdInfo': {'id': 'NEUR-2023-32484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Research participants', 'description': "Adults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest.", 'interventionNames': ['Diagnostic Test: Skin biopsy', 'Diagnostic Test: Speech testing', 'Diagnostic Test: Ultra high field 7T MRI']}], 'interventions': [{'name': 'Skin biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Skin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD', 'armGroupLabels': ['Research participants']}, {'name': 'Speech testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Speech Testing to quantify evolving signs of 5-HT RBD', 'armGroupLabels': ['Research participants']}, {'name': 'Ultra high field 7T MRI', 'type': 'DIAGNOSTIC_TEST', 'description': '7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration', 'armGroupLabels': ['Research participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joy Schmidt', 'role': 'CONTACT'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Joy Schmidt', 'role': 'CONTACT', 'email': 'schmidtj@umn.edu', 'phone': '(612) 624 -1456'}], 'overallOfficials': [{'name': 'Michael Howell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}