Clinical trial NCT00704327: Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
Official title: Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Decline
Keywords: Cognitive Functions
Brain Ischemia
Cerebral Atrophy
Dementia
Intracranial atherosclerosis
Memory impairment
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-24
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

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 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: Sami H. Erbay, M.D.
role: PRINCIPAL_INVESTIGATOR
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