Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-04-18 @ 8:02 PM
Study NCT ID:
NCT02273895
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012601', 'term': 'Scopolamine'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-22', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in EEG as a result of scopolamine administration', 'timeFrame': '1 hr after scopolamine administration', 'description': 'The EEG is recorded before, during and after scopolamine administration in order to monitor the effects scopolamine has on the brain as measured by EEG.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scopolamine, AD, EEG, MCI'], 'conditions': ['AD']}, 'referencesModule': {'references': [{'pmid': '17765604', 'type': 'BACKGROUND', 'citation': 'Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.'}, {'pmid': '20153691', 'type': 'RESULT', 'citation': "Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the electroencephalography (EEG) responses of three distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD) patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a group of controls. The main purpose of this comparison is to discover ways to use these responses to distinguish between the group of AD patients and controls in order to develop a diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this diagnostic tool can predict which member of the MCI group will develop AD later in life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy subjects:\n\n* Between 60-80 years of age.\n* Volunteers will have to be in good general health as determined by standard physical examination.\n* Normal Electrocardiograph (ECG)\n\nMCI subjects:\n\n* Diagnosed with MCI at the Memory Clinic at the Landspitali University Hospital using F 06,7 according to International Classification of Diseases (ICD) - 10.\n* Between 60-80 years of age.\n* Subjects need to score between 2 and 3 on the Global Deterioration Scale (GDS).\n* Normal ECG\n\nAlzheimer's patients:\n\n* Diagnosed with AD according to ICD - 10 in Follow up at the Memory Clinic at the Landspitali University Hospital.\n* Between 60-80 years of age.\n* Subjects need to score between 3-5 on the GDS.\n* Normal ECG\n* Treated with Reminyl® for the Alzheimer disease.\n\nExclusion Criteria:\n\n* Smoking or any other use of tobacco.\n* Taking neuroleptics or benzodiazepines (allowed to take oxazepam ad vesp).\n* Neurological-, cardiovascular-, gastrointestinal- or genitourinary disorders of medical importance.\n* Glaucoma or history of possibly raised intraocular pressure.\n* Impaired liver- or kidney function.\n* Hypersensitivity to Scopolamine or any component in the formulation.\n* Any indication of drug, alcohol or medicine abuse.\n* Participation in another investigational study at the same time."}, 'identificationModule': {'nctId': 'NCT02273895', 'briefTitle': "The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Mentis Cura'}, 'officialTitle': "Development of a Diagnostic Tool for Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'MC-CT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Scopolamine', 'interventionNames': ['Drug: Scopolamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MCI', 'description': 'Scopolamine', 'interventionNames': ['Drug: Scopolamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AD', 'description': 'Scopolamine', 'interventionNames': ['Drug: Scopolamine']}], 'interventions': [{'name': 'Scopolamine', 'type': 'DRUG', 'otherNames': ['Scopolamine hydrobromide'], 'description': '0.3 mg/mL, intravenously, once', 'armGroupLabels': ['AD', 'Control', 'MCI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jón Snædal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Landspitali University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mentis Cura', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Landspitali University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}