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OpenTrials
Completed

NCT Number: NCT03967535

Connectomics in Psychiatric Classification

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

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Alzheimers Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pick's Disease With Dementia Proteostasis Deficiencies TDP-43 Proteinopathies Tauopathies

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

MRI Brain Imaging

Device

Up to two Magnetic Resonance Imaging (MRI) scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.

Mental Health Assessment and Computerized Cognitive Test

Behavioral

Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.

Primary outcomes

  1. Magnetic Resonance Imaging (MRI) Brain Imaging

    Time frame: 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 outcomes

  1. DNA testing through saliva

    Time frame: 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.

Other outcomes

  1. Hair sample for cortisol measurement

    Time frame: within one month of study enrollment

    To see how cortisol levels can help characterize brain imaging findings

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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