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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967535
Other study ID # 201404123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date September 5, 2019

Study information

Verified date May 2020
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 85 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Hair sample for cortisol measurement To see how cortisol levels can help characterize brain imaging findings within one month of study enrollment
Primary 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 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
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