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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals between the ages of 45-85 with a diagnosis of Dementia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Individuals between 45-85 years old with no diagnosis of dementia. No intervention used	Device: MRI Brain Imaging; 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.; Behavioral: Mental Health Assessment and Computerized Cognitive Test; 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.
Dementia; Individuals between 45-85 years old with a diagnosis of dementia. No intervention used	Device: MRI Brain Imaging; 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.; Behavioral: Mental Health Assessment and Computerized Cognitive Test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI) Brain Imaging	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.	within one month of study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA testing through saliva	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.	within one month of study enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair sample for cortisol measurement	To see how cortisol levels can help characterize brain imaging findings	within one month of study enrollment

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Dementia; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 201404123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No