NCT00704327

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 21, 2017

Status Verified

August 1, 2017

Enrollment Period

9.1 years

First QC Date

June 20, 2008

Last Update Submit

December 19, 2017

Conditions

Keywords

Cognitive FunctionsBrain IschemiaCerebral AtrophyDementiaIntracranial atherosclerosisMemory impairment

Outcome Measures

Primary Outcomes (1)

  • Correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition using Mental Status Exam and Brain MRI exam

    One time visit, duration of MRI

Secondary Outcomes (1)

  • 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)

    Duration of study 3 years

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (14)

  • 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: 7604409BACKGROUND
  • 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: 10644864BACKGROUND
  • 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.

    PMID: 2646967BACKGROUND
  • 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

    BACKGROUND
  • 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: 16186527BACKGROUND
  • 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: 7554196BACKGROUND
  • 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: 8640967BACKGROUND
  • 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: 11028480BACKGROUND
  • 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: 11009264BACKGROUND
  • 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: 10694523BACKGROUND
  • 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: 7664421BACKGROUND
  • 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: 17089112BACKGROUND
  • 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: 15956522BACKGROUND
  • 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.

    PMID: 8988189BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionBrain IschemiaDementiaIntracranial ArteriosclerosisMemory Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesArteriosclerosisArterial Occlusive DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sami H. Erbay, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 21, 2017

Record last verified: 2017-08

Locations