Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-04-17 @ 8:30 AM
Study NCT ID:
NCT01487395
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacog battery', 'timeFrame': '15 days', 'description': '* cognitive tests (8 items of the Cantab battery) :\n\n * Motor screening\n * 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory)\n * 1 test for executive functions (Spatial Working Memory)\n * 2 tests for attention (Reaction Time, Rapid Visual Information Processing)\n * completed by a modified ADNI battery : ADAScog\n* imaging\n\n * fMRI\n * PET-FDG\n* neurophysiological\n\n * EEG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alzheimer', 'Donepezil', 'biomarkers', 'battery', 'cognition', 'imaging', 'neurophysiological'], 'conditions': ['Alzheimer Disease', 'Battery']}, 'descriptionModule': {'briefSummary': "The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs", 'detailedDescription': 'The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.\n\nThis multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).\n\n18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 year old male non-smoker subjects\n* Subject without cognitive impairment or cognitive complaint (Moca\\>26, Mac Nair scale\\<15)\n* Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)\n* Subject without major medical or surgical history\n* Subject without current chronic disease\n* Subject without current cerebral disease\n* Subject without vascular or metabolic risk factor\n* Subject without history or current mental disease or addiction (MINI)\n* Subject without lesion on MRI\n* Subject without abnormal electrical activities on EEG\n* Subject without use of chronic treatment or psychotropic drugs or substances\n* French speaker subject and able to understand the test instructions\n\nExclusion Criteria:\n\n* Subject with age \\< 18 years or \\> 30 years\n* Subject with dementia or cognitive decline identified by Moca \\< 26\n* Subject with history of brain disease (brain trauma, stroke, cerebral tumor,…)\n* Subject with major medical or surgical history\n* Subject with current chronic disease\n* Subject with current cerebral disease\n* Subject with vascular or metabolic risk factor\n* Subject with history or current mental disease or addiction\n* Subject with family history of young-onset dementia\n* Subject with family history of chronic or severe neurological or mental disease (first degree relatives)\n* Subject with lesion on MRI\n* Subject with abnormal electrical activities on EEG\n* Subject receiving a chronic treatment\n* Subject using chronically or acutely psychotropic drugs or substances\n* Subject with claustrophobia or contra-indication to MRI\n* Subject unable to understand the test instructions'}, 'identificationModule': {'nctId': 'NCT01487395', 'acronym': 'PharmacogWP3', 'briefTitle': 'Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers', 'orgStudyIdInfo': {'id': '2010_41'}, 'secondaryIdInfos': [{'id': '2010-023989-51', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Donepezil', 'description': 'Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.', 'interventionNames': ['Drug: Donepezil .']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo will be presented as tablet comparable to ARICEPT', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Donepezil .', 'type': 'DRUG', 'otherNames': ['ARICEPT ® Donépezil', 'Orally Disintegrating Tablets (ODT): 5 mg.'], 'description': 'Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.', 'armGroupLabels': ['Donepezil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': "CHRU de Lille/ Centre d'investigation Clinique", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CIC Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CIC Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Régis Bordet, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovative Medicines Initiative', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}