Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-03 @ 4:59 AM
Study NCT ID:
NCT03279835
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Speed Computerized Test (CSCT) score', 'timeFrame': 'at patient inclusion', 'description': 'allows the evaluation of the speed of the processing of the information'}, {'measure': 'Montreal Cognitive Assessment (MoCA) Score', 'timeFrame': 'at patient inclusion', 'description': 'allows the evaluation of the overall cognitive functioning'}], 'secondaryOutcomes': [{'measure': 'Paced Auditory Serial Addition Test (PASAT) score', 'timeFrame': 'at patient inclusion', 'description': 'allows to evaluate the concentration capacity'}, {'measure': 'Numeric Memory (WAIS-III location and back)', 'timeFrame': 'at patient inclusion', 'description': 'short-term memory evaluation and verbal working memory'}, {'measure': 'Score RL-RI16', 'timeFrame': 'at patient inclusion', 'description': 'allows the evaluation of episodic and long-term verbal memory'}, {'measure': 'Rey figure', 'timeFrame': 'at patient inclusion', 'description': 'allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning'}, {'measure': 'TMTB - TMTA Time Score', 'timeFrame': 'at patient inclusion', 'description': 'Assessment of Mental Flexibility'}, {'measure': 'Verbal fluency test', 'timeFrame': 'at patient inclusion', 'description': 'allows the evaluation of the verbal initiation and verbal language capacities'}, {'measure': 'IADL score', 'timeFrame': 'at patient inclusion', 'description': 'allows to evaluate the symptomatic character of the disorders'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in HIV infected patients comparing patients with and without HAART. Recent studies have demonstrated a specific HIV infected patients neurocognitive disorders profile. These cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed. This cognitive profile is similar to another highly documented one, described for another central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest and most severe disorder is the one related to the information processing speed. For the multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening. A digital version of this test (CSCT), has recently been developed in order to make this early evaluation easier. We hypothesize that CSCT alteration would also predict HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and personal consuming. This short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients infected with HIV-1', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients infected with HIV-1\n* Patients followed in outpatient service, over 18 years of age\n\nExclusion Criteria:\n\n* Patients infected with HIV-2\n* Patients with difficulty understanding the French language\n* Patients present with progressive opportunistic infection\n* Patients for whom a change of psychotropic treatment was performed in the last 3 weeks\n* Patients with drug and / or alcohol addiction\n* Patients with a history of psychiatric disorder\n* Patients with stroke, endocarditis or meningoencephalitis with severe neurological sequelae'}, 'identificationModule': {'nctId': 'NCT03279835', 'acronym': 'NEURACog', 'briefTitle': 'Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients', 'orgStudyIdInfo': {'id': '16-PP-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Absence of cognitive disorder', 'interventionNames': ['Other: Classic evaluation of neurocognitive functions', 'Other: New evaluation of neurocognitive functions']}, {'label': 'Asymptomatic cognitive disorder', 'interventionNames': ['Other: Classic evaluation of neurocognitive functions', 'Other: New evaluation of neurocognitive functions']}, {'label': 'Symptomatic cognitive impairment', 'interventionNames': ['Other: Classic evaluation of neurocognitive functions', 'Other: New evaluation of neurocognitive functions']}, {'label': 'HIV associated dementia', 'interventionNames': ['Other: Classic evaluation of neurocognitive functions', 'Other: New evaluation of neurocognitive functions']}], 'interventions': [{'name': 'Classic evaluation of neurocognitive functions', 'type': 'OTHER', 'description': 'Symbol Digit Modalities Test (SDMT)', 'armGroupLabels': ['Absence of cognitive disorder', 'Asymptomatic cognitive disorder', 'HIV associated dementia', 'Symptomatic cognitive impairment']}, {'name': 'New evaluation of neurocognitive functions', 'type': 'OTHER', 'description': 'Cognitive Speed Computerized Test (CSCT)', 'armGroupLabels': ['Absence of cognitive disorder', 'Asymptomatic cognitive disorder', 'HIV associated dementia', 'Symptomatic cognitive impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Pasteur 2 - Service de Neurologie', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}