Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:31 PM
Study NCT ID:
NCT05866367
Status:
TERMINATED
Last Update Posted:
2025-11-18
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials@HealthPartners.com', 'phone': '651-495-6363', 'title': 'Clinical Research Coordinator', 'organization': 'HealthPartners Institute Neuroscience Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'description': 'Study was terminated. No high dose individuals were consented prior to termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Watery eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain at needle insertion', 'notes': 'after lumbar puncture and after blood patch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Positional Headache', 'notes': 'Headache after lumbar puncture procedure. Required use of blood patch.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Concentration Over Time - Cerebrospinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'title': '0 minutes', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': '20 minutes', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': '40 minutes', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).', 'unitOfMeasure': 'µU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. No high dose individuals were consented prior to termination.'}, {'type': 'PRIMARY', 'title': 'Cmax of Insulin Concentration - Cerebrospinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'values below LLOQ', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by Cmax (peak concentration)', 'unitOfMeasure': 'uU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cmax was not summarized as most values were below the limit of detection of the assay.'}, {'type': 'PRIMARY', 'title': 'Tmax of Insulin Concentration - Cerebrospinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'values below LLOQ', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by Tmax (time of peak concentration)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Tmax was not calculated as most values were below the limit of detection of the assay.'}, {'type': 'PRIMARY', 'title': 'AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'values below LLOQ', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).', 'unitOfMeasure': 'uU*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AUC was not calculated as most values were below the limit of detection of the assay.'}, {'type': 'SECONDARY', 'title': 'Insulin Concentration Over Time - Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'title': '0 minutes', 'categories': [{'measurements': [{'value': '5.8', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': '10 minute', 'categories': [{'measurements': [{'value': '10.8', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': '20 minutes', 'categories': [{'measurements': [{'value': '9.75', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '9.75', 'spread': '5.16', 'groupId': 'OG000'}]}]}, {'title': '40 minutes', 'categories': [{'measurements': [{'value': '9.95', 'spread': '8.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. Serum insulin concentration will also be reported by Cmax (peak concentration), Tmax (time of peak concentration), and AUC (area under the curve, measured as time x concentration).', 'unitOfMeasure': 'µU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed. No high dose individuals were consented prior to closure.'}, {'type': 'SECONDARY', 'title': 'Cmax of Insulin Concentration - Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': '10.85', 'spread': '3.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by Cmax (peak concentration).', 'unitOfMeasure': 'uU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed. No high dose individuals were consented prior to closure.'}, {'type': 'SECONDARY', 'title': 'Tmax of Insulin Concentration - Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by Tmax (time of peak concentration).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed. No high dose individuals were consented prior to closure.'}, {'type': 'SECONDARY', 'title': 'AUC (Area Under the Curve) of Insulin Concentration - Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'OG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'classes': [{'categories': [{'measurements': [{'value': '382.25', 'spread': '115.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).', 'unitOfMeasure': 'uU*min/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed. No high dose individuals were consented prior to closure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'FG001', 'title': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nLow dose Regular Insulin: Regular insulin administered intranasally at either 40 IU'}, {'id': 'BG001', 'title': 'High Dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.\n\nHigh dose Regular insulin: Regular insulin administered intranasally at either 80 IU'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex assigned at birth', 'categories': [{'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study was closed. No high dose individuals were consented prior to closure.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-12', 'size': 2179872, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-11T13:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'We are closing this clinical protocol due to supply chain issues. We are no longer able to obtain the intranasal delivery device. We do not have adequate funding available to continue with an alternative intranasal delivery device.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2023-05-05', 'resultsFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-03', 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Concentration Over Time - Cerebrospinal Fluid', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).'}, {'measure': 'Cmax of Insulin Concentration - Cerebrospinal Fluid', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by Cmax (peak concentration)'}, {'measure': 'Tmax of Insulin Concentration - Cerebrospinal Fluid', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by Tmax (time of peak concentration)'}, {'measure': 'AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).'}], 'secondaryOutcomes': [{'measure': 'Insulin Concentration Over Time - Serum', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. Serum insulin concentration will also be reported by Cmax (peak concentration), Tmax (time of peak concentration), and AUC (area under the curve, measured as time x concentration).'}, {'measure': 'Cmax of Insulin Concentration - Serum', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by Cmax (peak concentration).'}, {'measure': 'Tmax of Insulin Concentration - Serum', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by Tmax (time of peak concentration).'}, {'measure': 'AUC (Area Under the Curve) of Insulin Concentration - Serum', 'timeFrame': '0-40 minutes post-intranasal administration', 'description': 'Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.\n\n12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is between ≥18 and ≤ 35 years of age\n2. Subject's body mass index is between \\>=18.5 and \\<=24.9\n3. Subject must be proficient in speaking English to comply with instructions and measures for the study\n4. Subject can provide written informed consent\n5. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal/surgically sterile.\n\nExclusion Criteria:\n\n1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.\n2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator\n3. Subject has participated in a clinical trial investigation within 3 months of this study.\n4. Subject has an insulin allergy\n5. Subject has Insulin-dependent diabetes\n6. Subject is pregnant or breast feeding\n7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion"}, 'identificationModule': {'nctId': 'NCT05866367', 'acronym': 'INI-CSF', 'briefTitle': 'Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose', 'orgStudyIdInfo': {'id': 'A21-299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose Intranasal Insulin', 'description': 'One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.', 'interventionNames': ['Drug: Low dose Regular Insulin']}, {'type': 'EXPERIMENTAL', 'label': 'High dose Intranasal Insulin', 'description': 'One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.', 'interventionNames': ['Drug: High dose Regular insulin']}], 'interventions': [{'name': 'Low dose Regular Insulin', 'type': 'DRUG', 'otherNames': ['Novolin-R'], 'description': 'Regular insulin administered intranasally at either 40 IU', 'armGroupLabels': ['Low dose Intranasal Insulin']}, {'name': 'High dose Regular insulin', 'type': 'DRUG', 'otherNames': ['Novolin-R'], 'description': 'Regular insulin administered intranasally at either 80 IU', 'armGroupLabels': ['High dose Intranasal Insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Leah R Hanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Neuroscience Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}