Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00692705
Status:
COMPLETED
Last Update Posted:
2009-01-23
First Post:
2008-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582909', 'term': 'AZD2995'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-22', 'studyFirstSubmitDate': '2008-06-05', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184', 'timeFrame': 'Radioligand (11C)AZD2995.1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. - Radioligand (11C) AZD2184.One PET for AD patients respective healthy volunteers.'}], 'secondaryOutcomes': [{'measure': 'To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.', 'timeFrame': '3-4 visits with tests for the AD patients. 3 visits with tests for the healthy volunteers. All tests are not done at every visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alzheimer´s Disease', 'amyloid deposits', 'Positron Emission Tomography', 'phase I'], 'conditions': ['Alzheimer´s Disease']}, 'descriptionModule': {'briefSummary': "The study is carried out in order to investigate if \\[11C\\]AZD2995, compared to \\[11C\\]AZD2184, is a more suitable PET ligand for in vivo imaging of β amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months.\n* Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2.\n* Clinically normal physical findings including normal blood pressure and pulse rate.\n\nExclusion Criteria:\n\n* Alzheimer´s Disease patients:\n* significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions\n* clinically significant illness within 2 weeks before the study start.\n* administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,.\n* Healthy volunteers; - clinically significant illness within 2 weeks before the study start, history of psychiatric or somatic disease/condition that may interfere.- first degree relative with dementia. Obvious deterioration of memory functions.'}, 'identificationModule': {'nctId': 'NCT00692705', 'acronym': 'PET', 'briefTitle': 'Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "Open Label Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid, to Determine and Compare in Vivo Brain Uptake and Distribution in Healthy Volunteers and Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'D0180C00018'}, 'secondaryIdInfos': [{'id': 'Eudract No. 2007-004842-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': "Alzheimer's Disease (AD) patients", 'interventionNames': ['Drug: Radioligand (11C)AZD2995', 'Drug: Radioligand (11C)AZD2184']}, {'type': 'OTHER', 'label': '2', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: Radioligand (11C)AZD2995', 'Drug: Radioligand (11C)AZD2184']}], 'interventions': [{'name': 'Radioligand (11C)AZD2995', 'type': 'DRUG', 'description': 'Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.', 'armGroupLabels': ['1', '2']}, {'name': 'Radioligand (11C)AZD2184', 'type': 'DRUG', 'description': 'Single dose of i.v solution. Once for AD patients respective healthy volunteers.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Maria E Jönhagen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden'}, {'name': 'Ingemar Bylesjö', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden'}, {'name': 'Emma Gyllenpalm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Märta Segerdahl, Medical Science Director', 'oldOrganization': 'AstraZeneca, Research and Development, Sweden'}}}}