Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01421056
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-17', 'releaseDate': '2015-10-19'}, {'releaseDate': '2016-02-05', 'unreleaseDateUnknown': True}], 'estimatedResultsFirstSubmitDate': '2015-10-19'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2014-01-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2011-08-05', 'dispFirstSubmitQcDate': '2014-01-07', 'studyFirstSubmitQcDate': '2011-08-19', 'dispFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.\n* Mini-Mental State Examination score higher than 24 at screening.\n* MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\\*-weighted gradient-recalled-echo (GRE) sequences.\n\nExclusion Criteria:\n\n* Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.\n* Any medical condition that could explain the patients cognitive deficits.\n* CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance\n* MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).\n* Geriatric Depression Scale (30-point scale) score \\> 9 at screening.\n* History of stroke.\n* Modified Hachinski ischemic scale score \\> 4 at screening.\n* Women of childbearing potential.\n* Vitamin B12 or folate deficiency.\n* Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.\n* Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.\n* Concomitant use of donepezil at doses \\> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.\n* Concomitant use of memantine at dose \\> 20 mg/day.\n* Concomitant use of psychoactive drugs (sedatives, hypnotics, etc)."}, 'identificationModule': {'nctId': 'NCT01421056', 'briefTitle': 'Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi USA, Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'CCD-1014-PR-0053 OLEP'}, 'secondaryIdInfos': [{'id': '2010-024270-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF 5074 1x', 'description': 'oral tablet, multidose', 'interventionNames': ['Drug: CHF 5074 1x']}, {'type': 'EXPERIMENTAL', 'label': 'CHF 5074 2x', 'description': 'oral tablet, multidose', 'interventionNames': ['Drug: CHF 5074 2x']}, {'type': 'EXPERIMENTAL', 'label': 'CHF 5074 3x', 'description': 'oral tablet, multidose', 'interventionNames': ['Drug: CHF 5074 3x']}], 'interventions': [{'name': 'CHF 5074 1x', 'type': 'DRUG', 'description': 'oral tablet, 1x, once a day in the morning for 24 weeks', 'armGroupLabels': ['CHF 5074 1x']}, {'name': 'CHF 5074 2x', 'type': 'DRUG', 'description': 'oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks', 'armGroupLabels': ['CHF 5074 2x']}, {'name': 'CHF 5074 3x', 'type': 'DRUG', 'description': 'oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks', 'armGroupLabels': ['CHF 5074 3x']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memory Enhancement Center of America, Inc.', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '08831', 'city': 'Monroe Twp', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memory Center of New Jersey, Inc.'}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memory Enhancement Center of NJ, Inc.', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Senior Adults Specialty Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Castellanza', 'country': 'Italy', 'facility': 'Clinica Santa Maria, Div Neurologia', 'geoPoint': {'lat': 45.61079, 'lon': 8.89616}}, {'city': 'Milan', 'country': 'Italy', 'facility': "Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Joel S. Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memory Enhancement Center of America, Inc.'}, {'name': 'Gabriella Bottini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osp. Niguarda Ca Granda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-19', 'type': 'RELEASE'}, {'date': '2015-11-17', 'type': 'RESET'}, {'date': '2016-02-05', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}], 'unpostedResponsibleParty': 'CERESPIR'}}}}