Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT01527695
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Study in Parkinson's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000602652', 'term': 'AZD3241'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).', 'timeFrame': 'baseline, 2-4 weeks'}, {'measure': 'Change of binding of [11C]PBR28 to TSPO measured by PET.', 'timeFrame': 'baseline, 7-8 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Change in plasma activity of myeloperoxidase (MPO).', 'timeFrame': 'baseline, up to 10 weeks'}, {'measure': 'Plasma concentrations of AZD3241.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Part of safety profile in terms of Columbia Suicide Severity Rating Scale.', 'timeFrame': 'Up to 10 weeks'}]}, 'conditionsModule': {'keywords': ['Phase IIa', 'AZD3241', 'microglia activation', 'safety', 'Pharmacodynamics and pharmacokinetics analyses', 'Parkinson patients'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.", 'detailedDescription': "A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)\n* Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening\n* Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational\n* The clinical diagnosis of patients must meet the criteria for "diagnosis of idiopathic Parkinson\'s disease" according to the modified UKPDS Brain Bank criteria (see Appendix E)\n* Modified Hoehn and Yahr stage 1 to 2\n\nExclusion Criteria:\n\n* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases\n* Patients who have undergone surgery for the treatment of Parkinson\'s disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery\n* Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist\n* Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John\'s Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;'}, 'identificationModule': {'nctId': 'NCT01527695', 'briefTitle': "PET Study in Parkinson's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'D0490C00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD3241', 'description': 'AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days', 'interventionNames': ['Drug: ER tablet 25 mg AZD3241', 'Drug: ER tablet 100 mg AZD3241']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'AZD3241 placebo bid for 8 weeks', 'interventionNames': ['Drug: Placebo for AZD3241 25 mg', 'Drug: Placebo for AZD3241 100 mg']}], 'interventions': [{'name': 'ER tablet 25 mg AZD3241', 'type': 'DRUG', 'description': '2 tablets twice daily for Day 1', 'armGroupLabels': ['AZD3241']}, {'name': 'ER tablet 100 mg AZD3241', 'type': 'DRUG', 'description': '1-6 tablets twice daily from Day 2 until Day 56±3 days', 'armGroupLabels': ['AZD3241']}, {'name': 'Placebo for AZD3241 25 mg', 'type': 'DRUG', 'description': '2 tablets twice daily for Day 1', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo for AZD3241 100 mg', 'type': 'DRUG', 'description': '1-6 tablets twice daily from Day 2 until Day 56±3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Reserach Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Vällingby', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.36441, 'lon': 17.87407}}], 'overallOfficials': [{'name': 'Per Svenningsson, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Bjorn Paulsson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Medical Science Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}