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Development and Decline of Brain and Cognition Through the Life Span

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880451
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
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:
National Institutes of Health Clinical Center (CC)
  Purpose
The protocol objectives are to enable prospective IRB review of research using human MRI scans and data collected under other branch protocols or extramural sources. By combining data from multiple sources the investigators will be able to conduct analyses that require large numbers of observations that exceed the numbers collected in any single study. They will also be able to stratify and subgroup the combined samples in different ways to permit analyses that would otherwise not be possible. The study population consists of normal individuals and clinical groups of all ages. Clinical groups will be added by amendment including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and Alzheimer's disease. The study design consists of 1) automated segmentation of MRI brain scans to obtain regional measurements of cortical thickness and volumetric measurements of brain structures including basal ganglia, 2) manual segmentation of brain structures and brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3) correlation analyses between MRI brain measurements and available demographic (e.g. gender) and physiological (e.g. BMI) data, statistical analysis of group differences where the groups are defined by diagnosis, age, gender or by other potentially useful classification. Since all data were collected under other protocols there are no additional risks or benefits associated with this protocol. This protocol combines MRI data from disparate sources and can provide important information regarding factors that may affect the comparability of MRI scans obtained from different sites using various types of MRI scanners and pulse sequences to generate MRI images. It will also enable the analysis of specific subgroups with sufficient numbers of observations for meaningful statistics....

Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Development and Decline of Brain and Cognition Through the Life Span

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: March 2009
Detailed Description:
The protocol objectives are to enable prospective IRB review of research using human MRI scans and data collected under other branch protocols or extramural sources. By combining data from multiple sources the investigators will be able to conduct analyses that require large numbers of observations that exceed the numbers collected in any single study. They will also be able to stratify and subgroup the combined samples in different ways to permit analyses that would otherwise not be possible. The study population consists of normal individuals and clinical groups of all ages. Clinical groups will be added by amendment including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and Alzheimer's disease. The study design consists of 1) automated segmentation of MRI brain scans to obtain regional measurements of cortical thickness and volumetric measurements of brain structures including basal ganglia, 2) manual segmentation of brain structures and brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3) correlation analyses between MRI brain measurements and available demographic (e.g. gender) and physiological (e.g. BMI) data, statistical analysis of group differences where the groups are defined by diagnosis, age, gender or by other potentially useful classification. Since all data were collected under other protocols there are no additional risks or benefits associated with this protocol. This protocol combines MRI data from disparate sources and can provide important information regarding factors that may affect the comparability of MRI scans obtained from different sites using various types of MRI scanners and pulse sequences to generate MRI images. It will also enable the analysis of specific subgroups with sufficient numbers of observations for meaningful statistics.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Data Analysis Only
  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): NCT00880451


Locations
United States, Maryland
National Institute of Mental Health (NIMH), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

ClinicalTrials.gov Identifier: NCT00880451     History of Changes
Other Study ID Numbers: 999909027
09-M-N027
First Submitted: April 10, 2009
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
Last Verified: October 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Children and Adolescents
Aging
Brain Imaging
MRI (Magnetic Resonance Imaging)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders