Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-30 @ 1:01 PM
Study NCT ID:
NCT04055532
Status:
WITHDRAWN
Last Update Posted:
2019-11-12
First Post:
2019-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Neurodegenerative Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}, {'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527756', 'term': "4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene"}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Lack of regulatory approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on Batteries of Cognitive Tests', 'timeFrame': '2-5 Years', 'description': 'Performance on batteries of cognitive tests as measured by the Modified Autobiographical Memory Interview (MAMI), Stroop Test, CDR-SOB, Spontaneous Speech Test, and the Neuropsychological Battery from the Uniform Data Set.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment (MCI)', 'Alzheimer Disease (AD)', 'Dementia With Lewy Bodies (DLB)', 'Frontotemporal Lobar Degeneration (FTLD)', 'Parkinsons Disease With Dementia (PDD)', 'Transient Epileptic Amnesia (TEA)', 'Temporal Lobe Epilepsy (TLE)', 'Spinocerebellar Ataxias (SCA)', 'HIV Associated Neurocognitive Disorder (HAND)', 'Amyotrophic Lateral Sclerosis (ALS)', 'Primary Lateral Sclerosis (PLS)']}, 'descriptionModule': {'briefSummary': 'The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.\n* Individual or group with a serious health condition for which there are no satisfactory standard treatments.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.\n2. Age 18 or older\n3. Reliable informant with frequent contact with participant\n4. Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2\n5. Able to undergo extensive psychometric testing\n\nExclusion Criteria:\n\n1. Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:\n\n * Past or present diagnosis of Korsakoff's syndrome\n * Alcohol or substance abuse preceding dementia \\& still present within 5 years of onset\n * Present untreated vitamin B12 or folate deficiency\n * Present untreated hypothyroidism\n * Past or present head trauma with persistent deficits\n * Present untreated syphilis\n * Past or present multiple sclerosis or another neuro-inflammatory disorder\n * Past or present vascular or multi-infarct dementia\n * Past or present diagnosis of huntington's disease\n * Past or present normal pressure hydrocephalus\n * Past or present central nervous system (CNS) lesions deemed to be clinically significant\n * Unresolved or present subdural hematoma\n * Past or present Ischemic Vascular Dementia\n * Past or present intracerebral hemorrhage\n * Present systematic liver disease\n * Present renal insufficiency requiring dialysis\n * Present encephalitis or meningitis\n * Present anxiety disorder (not due to dementia and requiring medication more than 3x per week)\n * Present severe periventricular white matter disease or greater than grade 4 white matter lesions\n * Present lacunar infarcts deemed to clinically significant\n * Present cortical stroke\n * Present respiratory condition requiring oxygen\n2. Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency\n3. Present inability to safely scan in an MRI\n4. Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.\n5. Present current medication likely to affect CNS functions:\n\n * Benzodiazepines (no triazolam, but other short-acting benzodiazepines are OK)\n * Antidepressant therapy with amitriptyline or doxepin or tx not stable during past year\n * Neuroleptics in the phenothiazine and haloperidol families (atypicals OK)\n * Narcotics (codeine is OK, but hold 24 hours before neuropsychological testing)\n * Anti-seizure medication outside of therapeutic ranges\n * Antihistamines (\\> 3x per week; hold 24 hours before neuropsychological testing)"}, 'identificationModule': {'nctId': 'NCT04055532', 'briefTitle': 'Biomarkers in Neurodegenerative Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Biomarkers in Neurodegenerative Diseases', 'orgStudyIdInfo': {'id': 'STUDY00007108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild Cognitive Impairment', 'interventionNames': ['Other: Neuraceq']}, {'label': "Alzheimer's Disease", 'interventionNames': ['Other: Neuraceq']}, {'label': 'Dementia with Lewy Bodies', 'interventionNames': ['Other: Neuraceq']}, {'label': 'Frontotemporal Lobar Dementia', 'interventionNames': ['Other: Neuraceq']}, {'label': "Parkinson's Disease with Dementia", 'interventionNames': ['Other: Neuraceq']}, {'label': 'Transient Epileptic Amnesia', 'interventionNames': ['Other: Neuraceq']}, {'label': 'Temporal Lobe Epilepsy', 'interventionNames': ['Other: Neuraceq']}, {'label': 'Spinocerebellar Ataxia', 'interventionNames': ['Other: Neuraceq']}, {'label': 'HIV-Associated Neurocognitive Disorder', 'interventionNames': ['Other: Neuraceq']}, {'label': 'Amyotrophic Lateral Sclerosis', 'interventionNames': ['Other: Neuraceq']}, {'label': 'Primary Lateral Sclerosis', 'interventionNames': ['Other: Neuraceq']}], 'interventions': [{'name': 'Neuraceq', 'type': 'OTHER', 'description': 'Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.', 'armGroupLabels': ["Alzheimer's Disease", 'Amyotrophic Lateral Sclerosis', 'Dementia with Lewy Bodies', 'Frontotemporal Lobar Dementia', 'HIV-Associated Neurocognitive Disorder', 'Mild Cognitive Impairment', "Parkinson's Disease with Dementia", 'Primary Lateral Sclerosis', 'Spinocerebellar Ataxia', 'Temporal Lobe Epilepsy', 'Transient Epileptic Amnesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Keith Vossel, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}