Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT01467960
Status:
UNKNOWN
Last Update Posted:
2013-10-30
First Post:
2011-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarahdassati@yahoo.it', 'phone': '+39 0471 471', 'title': 'Sarah Dassati', 'phoneExt': '471', 'organization': 'Villa Melitta'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and/or other \\[non-serious\\] adverse events weren not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Group I', 'description': 'Healthy Subjects aged 20-40', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II', 'description': 'Healthy Subjects aged 40-65', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group III', 'description': 'Healthy Subjects aged more than 65', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group A', 'description': 'Patients at Stage I, H\\&Y', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group B', 'description': 'Patients at Stage II, H\\&Y', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group C', 'description': 'Patients at stage \\> than II, H\\&Y', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection of Apolipoprotein D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'Healthy Subjects aged 20-40'}, {'id': 'OG001', 'title': 'Group II', 'description': 'Healthy Subjects aged 40-65'}, {'id': 'OG002', 'title': 'Group III', 'description': 'Healthy Subjects aged more than 65'}, {'id': 'OG003', 'title': 'Group A', 'description': 'Patients at Stage I, H\\&Y'}, {'id': 'OG004', 'title': 'Group B', 'description': 'Patients at Stage II, H\\&Y'}, {'id': 'OG005', 'title': 'Group C', 'description': 'Patients at stage \\> than II, H\\&Y'}], 'classes': [{'categories': [{'measurements': [{'value': '28.28', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '27.73', 'spread': '7.26', 'groupId': 'OG001'}, {'value': '34.61', 'spread': '9.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)", 'unitOfMeasure': 'microg / ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I', 'description': '30 Healthy Subjects aged 20-40'}, {'id': 'FG001', 'title': 'Group II', 'description': '30 Healthy Subjects aged 40-65'}, {'id': 'FG002', 'title': 'Group III', 'description': '30 Healthy Subjects aged more than 65'}, {'id': 'FG003', 'title': 'Group A', 'description': '30 Patients at Stage I, H\\&Y classification'}, {'id': 'FG004', 'title': 'Group B', 'description': '30 Patients at Stage II, H\\&Y classification'}, {'id': 'FG005', 'title': 'Group C', 'description': '30 Patients at Stage more than III, H\\&Y classification'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Enrollment of patients (PD) in 09/2013', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '30'}]}]}], 'recruitmentDetails': "90 healthy subjects are enrolled on the base of their age being classified in the groups I (20-40), II (40-65) and three (\\>than 65). 90 patients are enrolled on the base of their disease's stage (Hoehn and Yahr classification) being classified in the groups A (I, H\\&Y), B (II, H\\&Y) and C (\\> than II, H\\&Y)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '180', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I', 'description': 'Healthy Subjects aged 20-40'}, {'id': 'BG001', 'title': 'Group II', 'description': 'Healthy Subjects aged 40-65'}, {'id': 'BG002', 'title': 'Group III', 'description': 'Healthy Subjects aged more than 65'}, {'id': 'BG003', 'title': 'Group A', 'description': 'Patients at Stage I, H\\&Y'}, {'id': 'BG004', 'title': 'Group B', 'description': 'Patients at Stage II, H\\&Y'}, {'id': 'BG005', 'title': 'Group C', 'description': 'Patients at stage \\> than II, H\\&Y'}, {'id': 'BG006', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '120', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '180', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2011-10-30', 'resultsFirstSubmitDate': '2013-06-11', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-11', 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Apolipoprotein D', 'timeFrame': 'Baseline', 'description': "Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's"]}, 'referencesModule': {'references': [{'pmid': '16285', 'type': 'BACKGROUND', 'citation': 'Bennett MD. The time and duration of meiosis. Philos Trans R Soc Lond B Biol Sci. 1977 Mar 21;277(955):201-26. doi: 10.1098/rstb.1977.0012.'}, {'pmid': '21463', 'type': 'BACKGROUND', 'citation': 'Patterson D, Carnright DV. Biochemical genetic analysis of pyrimidine biosynthesis in mammalian cells: I. Isolation of a mutant defective in the early steps of de novo pyrimidine synthesis. Somatic Cell Genet. 1977 Sep;3(5):483-95. doi: 10.1007/BF01539120.'}, {'pmid': '19918', 'type': 'BACKGROUND', 'citation': 'Arnesen K, Nordstoga K. Ocular encephalitozoonosis (nosematosis) in blue foxes. Polyarteritis nodosa and cataract. Acta Ophthalmol (Copenh). 1977 Aug;55(4):641-51. doi: 10.1111/j.1755-3768.1977.tb05662.x.'}, {'pmid': '11058', 'type': 'BACKGROUND', 'citation': 'Weidler DJ, Sieck GC. A study of ion binding in the hemolymph of Periplaneta americana. Comp Biochem Physiol A Comp Physiol. 1977;56(1A):11-4. doi: 10.1016/0300-9629(77)90433-9. No abstract available.'}, {'pmid': '16755', 'type': 'BACKGROUND', 'citation': 'Bergdahl B, Andersson KE. Stability in vitro of methylproscillaridin. Eur J Clin Pharmacol. 1977 Apr 20;11(4):267-71. doi: 10.1007/BF00607675.'}, {'pmid': '14647', 'type': 'BACKGROUND', 'citation': 'Kovatsis A, Kovatsi-Kotsaki V, Elezoglou B, Kounenis G. Physiological antagonism between PGE2, PGA1, PGF1-alpha and NADP, beta-NAD on isolated rabbit jejunum. Arzneimittelforschung. 1976;26(11):1997-9.'}, {'pmid': '19930651', 'type': 'RESULT', 'citation': "Shankar GM, Walsh DM. Alzheimer's disease: synaptic dysfunction and Abeta. Mol Neurodegener. 2009 Nov 23;4:48. doi: 10.1186/1750-1326-4-48."}, {'pmid': '10601', 'type': 'RESULT', 'citation': 'Dalmark M. Chloride in the human erythrocyte: distribution and transport between cellular and extracellular fluids and structural features of the cell membrane. Prog Biophys Mol Biol. 1976;31(2):145-64. No abstract available.'}, {'pmid': '18957', 'type': 'RESULT', 'citation': 'Miller J, Wallace D, Grieco MH, Frenkel R, Larsen K. Double-blind trial of oral carbuterol in bronchial asthma. Ann Allergy. 1977 Jul;39(1):12-7.'}, {'pmid': '12801', 'type': 'RESULT', 'citation': 'Fall RR. Stabilization of an acetyl-coenzyme A carboxylase complex from Pseudomonas citronellolis. Biochim Biophys Acta. 1976 Dec 20;450(3):475-80. doi: 10.1016/0005-2760(76)90022-9.'}, {'pmid': '21876', 'type': 'RESULT', 'citation': 'Hong JS. An ecf mutation in Escherichia coli pleiotropically affecting energy coupling in active transport but not generation or maintenance of membrane potential. J Biol Chem. 1977 Dec 10;252(23):8582-8. No abstract available.'}, {'pmid': '19176', 'type': 'RESULT', 'citation': 'Kricka LJ, Carter TJ. A method for enhancing the stability of thiol-containing enzymes immobilised on nylon. Clin Chim Acta. 1977 Aug 15;79(1):141-7. doi: 10.1016/0009-8981(77)90471-5.'}], 'seeAlsoLinks': [{'url': 'http://www.villamelitta.it', 'label': 'Participating Centre for ApoD Detection'}]}, 'descriptionModule': {'briefSummary': "In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is the principle risk factor of Parkinson with the possibility of its development doubling every five years after 65. Because of the increase of the social longevity and aging as the main risk factor, there are many repercussions on the health system (hospital stays and pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's disease exerts an extremely negative impact on life's quality of the patient. In fact, because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced with the consequent development of the depression. Consequently, the early detection and treatment of Parkinson's is necessary.\n\nTo achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative stress-inflammation vicious cycle seems most promising candidate for diagnosis.", 'detailedDescription': 'Total participants: n=180.\n\nStudy Part 1:\n\nHealth persons: n=90; Groups of health persons: n=3; Subjects per group: n=30.\n\nStudy Part 2:\n\nPatients: n=90; Groups of patients: n=3; Subjects per group: n=30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the recruited subjects will be either healthy people group or patients with a defined diagnosis of Parkinson (classification of Hoehn and Yahr).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)\n* Persons \\> 20 years\n\nExclusion Criteria:\n\n* Patients with a neurodegenerative disorder different to Parkinson's disease\n* Patients, who are post-ictus and/or traumatic brain injury (TBI)\n* Patients, who are treated with antipsychotic drugs\n* Obese persons (BMI \\> 27)\n* Idiopathic normal pressure idrocephalus (INPI)\n* Paget's disease\n* Breast cancer\n* Adenocarcinoma of the prostate\n* Glucose-6-phosphate (GSD-I) deficiency\n* Insuline-resistance-related disorders"}, 'identificationModule': {'nctId': 'NCT01467960', 'acronym': 'ApoD', 'briefTitle': "Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Privatklinik Villa Melitta'}, 'officialTitle': "Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Melitta-ApoD-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Healthy Subjects aged 20-40'}, {'label': 'Group II', 'description': 'Healthy Subjects aged 40-65'}, {'label': 'Group III', 'description': 'Healthy Subjects aged more than 65'}, {'label': 'Group A', 'description': 'Patients at Stage I, H\\&Y classification'}, {'label': 'Group B', 'description': 'Patients at Stage II, H\\&Y classification'}, {'label': 'Group C', 'description': 'Patients at Stage more than III, H\\&Y classification'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Bolzano', 'state': 'Südtirol', 'country': 'Italy', 'facility': 'Privatklinik Villa Melitta', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}], 'overallOfficials': [{'name': 'Andreas Waldner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Privatklinik Villa Melitta'}, {'name': 'Sarah Dassati, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Privatklinik Villa Melitta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Privatklinik Villa Melitta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Andreas Waldner', 'investigatorAffiliation': 'Privatklinik Villa Melitta'}}}}