Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00704327|
Recruitment Status : Terminated (Investigator left the Institution)
First Posted : June 24, 2008
Last Update Posted : December 21, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition|
|Actual Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704327
|United States, Massachusetts|
|Lahey Clinic, Inc.|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||Sami H. Erbay, M.D.||Lahey Clinic, Inc.|