CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
Infinitomeprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04773041
NCT04773041N/ACompleted

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

HealthPartners Institute·observational·Posted Feb 26, 2021·Updated Nov 1, 2024

In Brief

An observational study evaluating Infinitome for Dementia With Lewy Bodies. Completed, enrolled 91 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 26, 2021
Enrollment StartApr 27, 2021
Primary CompletionFeb 8, 2023
Study CompletionJun 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago

Interventions

Infinitomeprocedure

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