Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00704327
Status:
TERMINATED
Last Update Posted:
2017-12-21
First Post:
2008-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'whyStopped': 'Investigator left the Institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2008-06-20', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition using Mental Status Exam and Brain MRI exam', 'timeFrame': 'One time visit, duration of MRI'}], 'secondaryOutcomes': [{'measure': 'Establish reliable imaging criteria to identify normal age induced changes versus pathologic process comparing Mental Status Exam with Brain MRI(measuring CSF and Brain volumes)', 'timeFrame': 'Duration of study 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive Functions', 'Brain Ischemia', 'Cerebral Atrophy', 'Dementia', 'Intracranial atherosclerosis', 'Memory impairment'], 'conditions': ['Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '7604409', 'type': 'BACKGROUND', 'citation': 'Ylikoski A, Erkinjuntti T, Raininko R, Sarna S, Sulkava R, Tilvis R. White matter hyperintensities on MRI in the neurologically nondiseased elderly. Analysis of cohorts of consecutive subjects aged 55 to 85 years living at home. Stroke. 1995 Jul;26(7):1171-7. doi: 10.1161/01.str.26.7.1171.'}, {'pmid': '10644864', 'type': 'BACKGROUND', 'citation': 'Kamata T, Hishida A, Takita T, Sawada K, Ikegaya N, Maruyama Y, Miyajima H, Kaneko E. Morphologic abnormalities in the brain of chronically hemodialyzed patients without cerebrovascular disease. Am J Nephrol. 2000 Jan-Feb;20(1):27-31. doi: 10.1159/000013551.'}, {'pmid': '2646967', 'type': 'BACKGROUND', 'citation': 'Muuronen A, Bergman H, Hindmarsh T, Telakivi T. Influence of improved drinking habits on brain atrophy and cognitive performance in alcoholic patients: a 5-year follow-up study. Alcohol Clin Exp Res. 1989 Feb;13(1):137-41. doi: 10.1111/j.1530-0277.1989.tb00298.x.'}, {'type': 'BACKGROUND', 'citation': 'National Heart, Lung, and Blood Institute(NHLBI), National Institutes of Health. Morbidity and mortality: 2000 chart book on cardiovascular, lung and blood disease. Abailable at: http://www.nhlbi.nih.gov/resources/docs/00chtbk.pdf. Accessed February 13, 2002'}, {'pmid': '16186527', 'type': 'BACKGROUND', 'citation': 'Knopman DS, Mosley TH, Catellier DJ, Sharrett AR; Atherosclerosis Risk in Communities (ARIC) Study. Cardiovascular risk factors and cerebral atrophy in a middle-aged cohort. Neurology. 2005 Sep 27;65(6):876-81. doi: 10.1212/01.wnl.0000176074.09733.a8.'}, {'pmid': '7554196', 'type': 'BACKGROUND', 'citation': 'Rumberger JA, Simons DB, Fitzpatrick LA, Sheedy PF, Schwartz RS. Coronary artery calcium area by electron-beam computed tomography and coronary atherosclerotic plaque area. A histopathologic correlative study. Circulation. 1995 Oct 15;92(8):2157-62. doi: 10.1161/01.cir.92.8.2157.'}, {'pmid': '8640967', 'type': 'BACKGROUND', 'citation': 'Arad Y, Spadaro LA, Goodman K, Lledo-Perez A, Sherman S, Lerner G, Guerci AD. Predictive value of electron beam computed tomography of the coronary arteries. 19-month follow-up of 1173 asymptomatic subjects. Circulation. 1996 Jun 1;93(11):1951-3. doi: 10.1161/01.cir.93.11.1951.'}, {'pmid': '11028480', 'type': 'BACKGROUND', 'citation': 'Arad Y, Spadaro LA, Goodman K, Newstein D, Guerci AD. Prediction of coronary events with electron beam computed tomography. J Am Coll Cardiol. 2000 Oct;36(4):1253-60. doi: 10.1016/s0735-1097(00)00872-x.'}, {'pmid': '11009264', 'type': 'BACKGROUND', 'citation': 'Wong ND, Hsu JC, Detrano RC, Diamond G, Eisenberg H, Gardin JM. Coronary artery calcium evaluation by electron beam computed tomography and its relation to new cardiovascular events. Am J Cardiol. 2000 Sep 1;86(5):495-8. doi: 10.1016/s0002-9149(00)01000-6.'}, {'pmid': '10694523', 'type': 'BACKGROUND', 'citation': 'Raggi P, Callister TQ, Cooil B, He ZX, Lippolis NJ, Russo DJ, Zelinger A, Mahmarian JJ. Identification of patients at increased risk of first unheralded acute myocardial infarction by electron-beam computed tomography. Circulation. 2000 Feb 29;101(8):850-5. doi: 10.1161/01.cir.101.8.850.'}, {'pmid': '7664421', 'type': 'BACKGROUND', 'citation': 'Simon A, Giral P, Levenson J. Extracoronary atherosclerotic plaque at multiple sites and total coronary calcification deposit in asymptomatic men. Association with coronary risk profile. Circulation. 1995 Sep 15;92(6):1414-21. doi: 10.1161/01.cir.92.6.1414.'}, {'pmid': '17089112', 'type': 'BACKGROUND', 'citation': 'Erbay S, Han R, Baccei S, Krakov W, Zou KH, Bhadelia R, Polak J. Intracranial carotid artery calcification on head CT and its association with ischemic changes on brain MRI in patients presenting with stroke-like symptoms: retrospective analysis. Neuroradiology. 2007 Jan;49(1):27-33. doi: 10.1007/s00234-006-0159-z. Epub 2006 Nov 7.'}, {'pmid': '15956522', 'type': 'BACKGROUND', 'citation': 'Babiarz LS, Yousem DM, Bilker W, Wasserman BA. Middle cerebral artery infarction: relationship of cavernous carotid artery calcification. AJNR Am J Neuroradiol. 2005 Jun-Jul;26(6):1505-11.'}, {'pmid': '8988189', 'type': 'BACKGROUND', 'citation': "Yue NC, Arnold AM, Longstreth WT Jr, Elster AD, Jungreis CA, O'Leary DH, Poirier VC, Bryan RN. Sulcal, ventricular, and white matter changes at MR imaging in the aging brain: data from the cardiovascular health study. Radiology. 1997 Jan;202(1):33-9. doi: 10.1148/radiology.202.1.8988189."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether or not cerebral atrophy scores obtained from a brain MRI can correlate with Cognitive Test results. These results hope to demonstrate a link between cerebral ischemic/degenerative changes shown on the MRI and cognition functions results.', 'detailedDescription': "Preliminary evidence indicates that intracranial atherosclerosis may predict incident cerebrovascular events and central atrophy. Age induced changes on cerebral tissue in adulthood is witnessed as atrophy and well know ischemic changes on imaging studies. There is no consensus at this time what constitutes normal, age induced atrophy and pathologic atrophy on imaging studies. The same challenge is also encountered for ischemic cerebral parenchymal change.\n\nUntil recently there have been several important limitations in this research 1) Measurement of cerebral tissue loss and amount of ischemic insult was based on a qualitative grading (2) There was no cognitive testing. With Advancements in software technology that have now allowed for measurements of CSF and brain volumes in reliable and reproducible ways and the neuroradiologist having access to the subject's Neurological Cognitive Testing Scores, this study will objectively measure MRI findings and correlate them with the level of cognitive function.\n\nThis study will look at subjects who have undergone cognitive testing from the Neurology Clinic and then referred for an MRI brain exam, as standard of care testing. The MRI information will be acquired by volumetric technique for calculation of brain and CSF volumes and MRI data will be plotted against the cognitive test results.\n\nThe results of this study will be to correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition and to establish reliable imaging criteria that can help identify normal, age induced versus pathologic. Information obtained will shed light to cognitive effects and imaging appearance of: Separation of normal age related changes from pathologic states, changes leading to dementia and normal pressure hydrocephalus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects identified from Neurology Department who have already undergone Cognitive Testing and have been referred for an MRI exam', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects older than 50 years of age\n* Subjects who have undergone Cognitive Testing\n* Subjects who can cooperate and give informed consent\n\nExclusion Criteria:\n\n* Subjects with known medical conditions predisposing them for atrophy such as: Chronic renal failure, HIV, head/neck tumors, prior radiation, post- traumatic brain disorder, metabolic disorders of brain, polysubstance abuse, and steroid use'}, 'identificationModule': {'nctId': 'NCT00704327', 'briefTitle': 'Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Lahey Clinic'}, 'officialTitle': 'Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition', 'orgStudyIdInfo': {'id': '2008-029'}}, 'contactsLocationsModule': {'locations': [{'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic, Inc.', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}], 'overallOfficials': [{'name': 'Sami H. Erbay, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahey Clinic, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahey Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}