Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 3:51 PM
Study NCT ID:
NCT01433666
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roflumilast and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C424423', 'term': 'Roflumilast'}, {'id': 'D058988', 'term': 'Phosphodiesterase 4 Inhibitors'}], 'ancestors': [{'id': 'D010726', 'term': 'Phosphodiesterase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-09-13', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of words remembered on Verbal learning task', 'timeFrame': '1hr after drug intake', 'description': '30 monosyllable words will be displayed on a computer screen. Immediately after the presentation and after 45 minutes, subjects will be asked to report as much words as they remember. In addition, a recognition trial is conducted. Here, 30 words will be presented; 15 new words and 15 from the original list. Subjects have to indicate whether the word is old or new.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '29098341', 'type': 'RESULT', 'citation': 'Heckman PRA, Van Duinen MA, Blokland A, Uz T, Prickaerts J, Sambeth A. Acute administration of roflumilast enhances sensory gating in healthy young humans in a randomized trial. Psychopharmacology (Berl). 2018 Jan;235(1):301-308. doi: 10.1007/s00213-017-4770-y. Epub 2017 Nov 3.'}, {'pmid': '29241652', 'type': 'RESULT', 'citation': 'Van Duinen MA, Sambeth A, Heckman PRA, Smit S, Tsai M, Lahu G, Uz T, Blokland A, Prickaerts J. Acute administration of roflumilast enhances immediate recall of verbal word memory in healthy young adults. Neuropharmacology. 2018 Mar 15;131:31-38. doi: 10.1016/j.neuropharm.2017.12.019. Epub 2017 Dec 11.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007%2Fs00213-017-4770-y', 'label': 'Published sensory gating data'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 35 years of age\n* Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),\n* Body mass index between 18.5 and 30\n* Willingness to sign an informed consent.\n* Positive evaluation on the memory screening\n\nExclusion Criteria:\n\n* History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness\n* First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)\n* Excessive drinking (\\>20 glasses of alcohol containing beverages per week)\n* Pregnancy or lactation\n* Use of chronic medication other than oral contraceptives\n* Use of recreational drugs in the 2 weeks preceding participation\n* Smoking\n* Orthostatic hypotension\n* Lactose intolerance\n* Sensory or motor deficits which could reasonably be expected to affect test performance'}, 'identificationModule': {'nctId': 'NCT01433666', 'acronym': 'EEGrofl', 'briefTitle': 'Roflumilast and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study', 'orgStudyIdInfo': {'id': 'METC11-3-035'}, 'secondaryIdInfos': [{'id': 'ZonMw (the Netherlands)', 'type': 'OTHER_GRANT', 'domain': '95110091'}, {'id': '2011-002070-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'roflumilast 100ug', 'interventionNames': ['Drug: roflumilast (EU: Daxas, USA: Daliresp)', 'Drug: roflumilast']}, {'type': 'EXPERIMENTAL', 'label': 'roflumilast 300ug', 'interventionNames': ['Drug: roflumilast (EU: Daxas, USA: Daliresp)', 'Drug: roflumilast']}, {'type': 'EXPERIMENTAL', 'label': 'roflumilast1000ug', 'interventionNames': ['Drug: roflumilast (EU: Daxas, USA: Daliresp)', 'Drug: roflumilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo', 'Drug: roflumilast']}], 'interventions': [{'name': 'roflumilast (EU: Daxas, USA: Daliresp)', 'type': 'DRUG', 'description': 'Acute intervention: 1 time each dose on different days. Capsulated', 'armGroupLabels': ['roflumilast 100ug', 'roflumilast 300ug', 'roflumilast1000ug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Acute intervention: single administration, capsulated form.', 'armGroupLabels': ['placebo']}, {'name': 'roflumilast', 'type': 'DRUG', 'otherNames': ['Daxas', 'Daliresp', 'PDE4-inhibitor'], 'description': 'Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.', 'armGroupLabels': ['placebo', 'roflumilast 100ug', 'roflumilast 300ug', 'roflumilast1000ug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University, Faculty of Psychology and Neuroscience', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Jos H. Prickaerts, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}