Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 6:39 AM
Study NCT ID:
NCT01505504
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2012-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirtazapine in Alzheimer-associated Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Weight Loss', 'Mixed Dementia', 'Dementia']}, 'descriptionModule': {'briefSummary': 'Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has weight loss as a frequent side effect.\n\nThe aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can counteract weight loss in patients with AD or mixed dementia (AD + vascular).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with established diagnosis of AD or mixed dementia with reported weight loss', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AD or mixed dementia\n* documented weight loss\n* mirtazapine 30 mg explicitly prescribed against weight loss\n\nExclusion Criteria:\n\n* no treatment compliance\n* other causes of weight loss\n* other interventions against weight loss'}, 'identificationModule': {'nctId': 'NCT01505504', 'briefTitle': 'Mirtazapine in Alzheimer-associated Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Mirtazapine in Alzheimer-associated Weight Loss: a Retrospective Phase IV Study', 'orgStudyIdInfo': {'id': 'MIRTA-2012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mirtazapine', 'type': 'DRUG', 'otherNames': ['Remergon'], 'description': '30 mg at bedtime'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kurt Segers', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}