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NCT Number: NCT04773041

Dementia With Lewy Bodies - Infinitome

Dementia with Lewy bodies (DLB) is the second most common cause of dementia and is associated with parkinsonism, hallucinations, and cognitive fluctuations. Diagnosis is often either missed or delayed due to physician lack of familiarity with characteristic features, the inability of structural MRI to detect a pathological signature for this condition, and the lack of healthcare provider access to "indicative biomarkers" that are either unavailable at community clinics or costly due to lack of insurance coverage. The role of resting state function MRI (rs-fMRI) as a diagnostic biomarker has been underexplored in this disease. We propose using a novel cloud-based automated imaging software processing program that identifies abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI) and data from the Human Connectome Project (HCP). Furthermore, the imaging protocol to capture this data is relatively short (15 minutes) and can be performed at most imaging centers, lending potential clinical applicability to this study. We intend to study dysfunctional large scale brain networks (LSBNs) in DLB by comparing rs-fMRI imaging data in this population with cognitively normal (CN) and mild Alzheimer's disease (AD) subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI)-2/3 database.

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Key information

Conditions

Dementia With Lewy Bodies Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

About this study

Omniscient, a for-profit, Sydney, Australia-based company, created the cloud-based software Infinitome, a program that utilizes data from the Human Connectome Project (HCP) together with machine learning to analyze diffusion tensor and resting-state fMRI imaging data from remote sites. The foundation for this imaging tool is based upon the HCP atlas, which has also informed prior publications from our group, including the Connectomic Atlas of the Human Cerebrum (Baker, Burks, Briggs, Conner, et al. 2018). The Infinitome program creates a subject specific version of the Human Connectome Project Multimodal Parcellation (HCP-MMP1) atlas using diffusion tractography. Analytics are performed on both diffusion tensor imaging and rs-fMRI. Outlier detection using a tangent space connectivity matrix is performed by comparing results with a subset of 300 normal HCP subject fMRI samples to determine the range of normal correlations for each regions of interest in a large scale brain network which include:

  • Locus coeruleus vs. Nucleus basalis of Meynert
  • Locus coeruelus vs. Intralaminar nucleus of the thalamus
  • Nucleus basalis of Meynert vs. Intralaminar nuclei of the thalamus
  • FST in the vs. Area PH in the lateral occipital lobe
  • Substantia nigra vs. Caudate nucleus Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40-90 years
  • Established DLB diagnosis
  • Mini mental status exam (MMSE) >15

Exclusion criteria

  • Other forms of dementia including, but not limited to Alzheimer's dementia, frontotemporal dementia, vascular dementia, normal pressure hydrocephalus (NPH), etc,
  • Inability to tolerate brain function magnetic resonance imaging (fMRI)
  • Risk of brain fMRI due to implants or metal.

Treatment and study plan

Infinitome

Procedure

All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.

Primary outcomes

  1. Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.

    Time frame: Baseline

    Identify functional connectivity scores between pairs of large scale brain networks as determined by connectomic analysis using rs-fMRI Infinitome software in order to compare functional connectivity scores between groups. Eight parcellation pairs were chosen as primary pairs of interest.

    For each parcellation pair - Range [-1,1]. Higher positive score indicates greater connectivity.

Secondary outcomes

  1. Correlation of Clinical Measures and Functional Connectivity Scores

    Time frame: Baseline

    Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB . Range [-1,1]. Higher score indicates greater connectivity.

    Correlation of:

    • Caudate R/Substantia Nigra R and Clock Drawing Test
    • Caudate R/Substantia Nigra R and ADAS Number Cancellation
    • PH R/FST R and ADAS Construction Praxis
    • PH R/FST R and Clock Drawing Test

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Connectomic Analysis in Dementia With Lewy Bodies: A Potential Diagnostic Imaging Biomarker

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
Nov 1, 2024

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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