Connectomics in Psychiatric Classification

Completed

• Conditions: Dementia; Dementia Alzheimers; Frontotemporal Dementia; Pick's Disease With Dementia
• Interventions: Device: MRI Brain Imaging; Behavioral: Mental Health Assessment and Computerized Cognitive Test

• Registration Number: NCT03967535
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.

Detailed Description

This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-26
• Study First Posted: 2019-05-30
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ages 45-85
• Has consented to participate or has an LAR present that has consented to participate
• DSM-5 diagnosis of Dementia

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Exclusion Criteria

• Any genetic disorder, such as cystic fibrosis or sickle cell disease
• Multiple Sclerosis
• Cerebral Palsy
• Loss of consciousness for >30 minutes
• Pregnancy
• Hospitalization for stroke, brain aneurysm, brain hemorrhage, or subdural hematoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dementia	MRI Brain Imaging	Individuals between 45-85 years old with a diagnosis of dementia. No intervention used
Control	MRI Brain Imaging	Individuals between 45-85 years old with no diagnosis of dementia. No intervention used
Control	Mental Health Assessment and Computerized Cognitive Test	Individuals between 45-85 years old with no diagnosis of dementia. No intervention used
Dementia	Mental Health Assessment and Computerized Cognitive Test	Individuals between 45-85 years old with a diagnosis of dementia. No intervention used

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI) Brain Imaging	within one month of study enrollment	The current project aims to uncover latent, homogenous, connectivity phenotypes using neuroimaging tools, which are free from the limitations of traditional diagnostic boundaries, and which correlate with clinical characteristics. The investigator will use resting state functional connectivity MRI (rs-fcMRI), diffusion MRI (dMRI) and tract-based spatial statistics (TBSS) to identify brain signatures that cut across psychiatric disorders.

Secondary Outcome Measures

Name	Time	Method
DNA testing through saliva	within one month of study enrollment	Saliva samples will be collected from participants for DNA extraction and the development of lymphoblastoid cell lines. DNA is used for research purposes only, for studies assessing brain connectivity.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States