Development and Decline of Brain and Cognition Through the Life Span

Alzheimer's Disease Clinical Trial

Official title: Development and Decline of Brain and Cognition Through the Life Span

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT00880451
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: March 2009