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Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
This study is currently recruiting participants.
Verified by Lahey Clinic, June 2008
Sponsored by: Lahey Clinic
Information provided by: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00704327
  Purpose

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.


Condition
Cognitive Decline

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Cross-Sectional
Official Title: Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition using Mental Status Exam and Brain MRI exam [ Time Frame: One time visit, duration of MRI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Duration of study 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

Until 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.

This 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.

The 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects identified from Neurology Department who have already undergone Cognitive Testing and have been referred for an MRI exam

Criteria

Inclusion Criteria:

  • Subjects older than 50 years of age
  • Subjects who have undergone Cognitive Testing
  • Subjects who can cooperate and give informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704327

Contacts
Contact: Sami H. Erbay, M.D. 781-744-8170 Sami.Erbay@Lahey.org

Locations
United States, Massachusetts
Lahey Clinic, Inc. Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Sami H. Erbay, M.D.     781-744-8170     Sami.Erbay@Lahey.org    
Sub-Investigator: Grace M. Lee, M.D.            
Sub-Investigator: Yuval Zabar, M.D.            
Sub-Investigator: Karen Hanley            
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Sami H. Erbay, M.D. Lahey Clinic, Inc.
  More Information

Publications:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Epub 2006 Nov 7.
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.
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.

Responsible Party: Lahey Clinic, Inc. ( Sami H. Erbay, M.D. )
Study ID Numbers: 2008-029
Study First Received: June 20, 2008
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00704327  
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Cognitive Functions
Brain Ischemia
Cerebral Atrophy
Dementia
Intracranial atherosclerosis
Memory impairment

Study placed in the following topic categories:
Atherosclerosis
Brain Ischemia
Atrophy
Ischemia
Dementia

ClinicalTrials.gov processed this record on January 16, 2009