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NCT04773041 · ClinicalTrials.gov registry record

Dementia With Lewy Bodies - Infinitome

A clinical trial, sponsored by HealthPartners Institute.

Completed
Registry status
91
Enrollment target

NCT04773041: Completed study, sponsored by HealthPartners Institute.

NCT04773041 is a clinical trial that has completed, run by HealthPartners Institute. The registered enrollment target is 91 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04773041 has completed, sponsored by HealthPartners Institute.

COMPLETED
Registry status
91 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • PROCEDURE Infinitome

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2021-04-27
Est. Completion 2023-06-19
HealthPartners Institute

146 total trials

What the finished NCT04773041 record still lists

NCT04773041 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 91 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Infinitome is the first listed.

NCT04773041 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04773041 about?

NCT04773041 is a clinical study titled "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 ...

What is the current status of trial NCT04773041?

This trial is currently completed. The enrollment target is 91 participants. The study started on 2021-04-27. Estimated completion is 2023-06-19.

What interventions are being tested in trial NCT04773041?

The interventions under investigation include: Infinitome (PROCEDURE).

Who is sponsoring clinical trial NCT04773041?

This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04773041, the US trial registry maintained by the National Library of Medicine. NCT04773041 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.