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Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition

This study has been terminated.
(Investigator left the Institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704327
First Posted: June 24, 2008
Last Update Posted: August 24, 2017
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.
Information provided by (Responsible Party):
Lahey Clinic
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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 ]

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 ]

Enrollment: 170
Actual Study Start Date: February 2008
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Sami H. Erbay, M.D. Lahey Clinic, Inc.
  More Information

Publications:
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

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00704327     History of Changes
Other Study ID Numbers: 2008-029
First Submitted: June 20, 2008
First Posted: June 24, 2008
Last Update Posted: August 24, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders