N/A
N=91
Dementia With Lewy Bodies - Infinitome
Dementia With Lewy Bodies
Bottom Line
View on ClinicalTrials.gov: NCT04773041 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Functional Connectivity Scores Between Pairs of Large Scale Brain Networks. — 0.164; 0.374; 0.344; 0.340 connectivity score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Infinitome (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Connectivity Scores Between Pairs of Large Scale Brain Networks. |
0.164; 0.374; 0.344; 0.340; 0.517; 0.442 | — |
| SECONDARY Correlation of Clinical Measures and Functional Connectivity Scores |
-0.50; -0.23; 0.26; -0.65; -0.01; -0.06 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04773041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.