Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01335633
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2011-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychometric Validation of Cognitive Endpoints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MS', 'Neuropsychological tests'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with Multiple Sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 65 years old (inclusive).\n* History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis\n* Physically able to see the testing materials and complete the tests\n* Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.\n\nExclusion Criteria:\n\n* A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.\n* Untreated major depression or untreated anxiety disorder.\n* History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.\n* History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.\n* A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.\n* History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1.\n* Active bacterial or viral infection.\n* Use of marijuana within 2 months prior to Study Day 1or at any time during the study\n* Alcohol consumption within 24 hours of either test session.\n* Unable to comply with study requirements.\n* Expected survival time of less than 3 months."}, 'identificationModule': {'nctId': 'NCT01335633', 'briefTitle': 'Psychometric Validation of Cognitive Endpoints', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Psychometric Validation of Cognitive Endpoints', 'orgStudyIdInfo': {'id': '691-11 PVCE'}}, 'contactsLocationsModule': {'locations': [{'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Hospital Multiple Sclerosis Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Lauren S. Caruso', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'overallOfficials': [{'name': 'John DeLuca, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kessler Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President of Research', 'investigatorFullName': 'John DeLuca', 'investigatorAffiliation': 'Kessler Foundation'}}}}