Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT02064166
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2014-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, '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': 'pnovak2@bwh.harvard.edu', 'phone': '617-732-8896', 'title': 'Peter Novak, MD PhD', 'organization': "Brigham & Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Insulin', 'description': '40 IU of intranasal insulin daily Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo arm using intranasal normal saline Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Verbal Fluency FAS (F, A or S Words) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'FAS score in the insulin group at baseline Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'FAS score in the insulin group post treatment\n\nTreatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'FAS score in the placebo group at baseline Placebo arm using intranasal normal saline\n\nPlacebo arm: normal saline, daily, intranasally, for 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '32.8', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '30.8', 'spread': '7.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.', 'unitOfMeasure': 'Words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Hoehn and Yahr Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'HY Scale in the insulin group at baseline'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'HY scale in the insulin group post treatment'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'HY scale in placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'HY scale in placebo group post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '0.38', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'MOCA Scale in insulin group at baseline'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'MOCA scale in insulin group post treatment'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'MOCA score in the placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'MOCA score in the placebo group post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '28.2', 'spread': '0.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory Score (BDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'BDI Scale in the insulin group at baseline'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'BDI scale in the insulin group post-treatment'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'BDI score in the placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'BDI score in the placebo group post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '12.8', 'spread': '7.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'UPDRS III Scale in the insulin group at baseline'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'UPDRS III Scale in the insulin group at post treatment'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'UPDRS III Scale in the placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'UPDRS III Scale in the insulin group post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '31.7', 'spread': '13.3', 'groupId': 'OG002'}, {'value': '30.5', 'spread': '15.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gait Analysis (4-meter Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Baseline', 'description': 'Stride interval in the insulin group at baseline'}, {'id': 'OG001', 'title': 'Insulin Post Treatment', 'description': 'Stride interval in the insulin group post treatment'}, {'id': 'OG002', 'title': 'Placebo Baseline', 'description': 'Stride interval in placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo Post Treatment', 'description': 'Stride interval in placebo group post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '19.6', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.', 'unitOfMeasure': 'inch', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Brief Visuospatial Memory Test-Revised (BVMT-R)', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin', 'description': 'Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily\n\nIntranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo arm using intranasal normal saline\n\nPlacebo arm: normal saline, daily, intranasally, for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin', 'description': '40 IU of intranasal insulin daily\n\nIntranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo arm using intranasal normal saline\n\nIntranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.'}, {'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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2014-02-13', 'resultsFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-21', 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)", 'timeFrame': 'Baseline and post-treatment', 'description': 'UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.'}, {'measure': 'Gait Analysis (4-meter Test)', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.'}, {'measure': 'Brief Visuospatial Memory Test-Revised (BVMT-R)', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.'}], 'primaryOutcomes': [{'measure': 'Change in Verbal Fluency FAS (F, A or S Words) Total Score', 'timeFrame': 'Baseline and post-treatment', 'description': 'Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.'}], 'secondaryOutcomes': [{'measure': 'Modified Hoehn and Yahr Scale', 'timeFrame': 'Baseline and post-treatment', 'description': 'The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.'}, {'measure': 'Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline and post-treatment', 'description': 'The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.'}, {'measure': 'Beck Depression Inventory Score (BDI)', 'timeFrame': 'Baseline and post-treatment', 'description': 'Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Multiple system atrophy', 'Intranasal', 'Insulin'], 'conditions': ['Parkinson Disease', 'Multiple System Atrophy']}, 'referencesModule': {'references': [{'pmid': '31022213', 'type': 'DERIVED', 'citation': 'Novak P, Pimentel Maldonado DA, Novak V. Safety and preliminary efficacy of intranasal insulin for cognitive impairment in Parkinson disease and multiple system atrophy: A double-blinded placebo-controlled pilot study. PLoS One. 2019 Apr 25;14(4):e0214364. doi: 10.1371/journal.pone.0214364. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.\n\nThe proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.\n\nThis proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.\n\nThe study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females older than 17 years.\n2. Clinical diagnosis of Parkinson disease or multiple system atrophy.\n3. Provide written informed consent to participate in the study.\n4. Understand that they may withdraw their consent at any time.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating.\n2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial.\n3. History of dementia.\n4. Unable to walk without help for at least 1 minute.\n5. History of allergic reaction to insulin.\n6. The presence of inflammation of nasal cavity that may prevents absorption of insulin."}, 'identificationModule': {'nctId': 'NCT02064166', 'briefTitle': 'Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy', 'orgStudyIdInfo': {'id': 'PN-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin', 'description': '40 IU of intranasal insulin daily', 'interventionNames': ['Drug: Intranasal Insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo arm using intranasal normal saline', 'interventionNames': ['Drug: Intranasal Insulin']}], 'interventions': [{'name': 'Intranasal Insulin', 'type': 'DRUG', 'otherNames': ['Novolin R'], 'description': '1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;\n2. placebo arm: normal saline, daily, intranasally, for 4 weeks.', 'armGroupLabels': ['Insulin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': "Peter Novak', MD,PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Former Associate Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Novak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Former Faculty member', 'investigatorFullName': 'Peter Novak', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}