Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Lahey Clinic
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00704327
First received: June 20, 2008
Last updated: June 11, 2014
Last verified: June 2014
  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 ] [ 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 ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00704327     History of Changes
Other Study ID Numbers: 2008-029
Study First Received: June 20, 2008
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014