Clinical trial NCT00880451: Development and Decline of Brain and Cognition Through the Life Span
Official title: Development and Decline of Brain and Cognition Through the Life Span
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Children and Adolescents
Aging
Brain Imaging
MRI (Magnetic Resonance Imaging)
MRI
Magnetic Resonance Imaging
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-04-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: 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.

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 criteria: * Data Analysis Only

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Mental Health (NIMH), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Francois M Lalonde, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: