An observational study in Dementia With Lewy Bodies, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by HealthPartners Institute · Observational
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.
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:
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 91 is below the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for DLB and subjects included in the ADNI database.
Exclusion Criteria:
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Procedure: Infinitome
Patients diagnosed with AD age and sex-matched, selected from the ADNI database.
Procedure: Infinitome
Patients diagnosed with normal cognition age and sex-matched, selected from the ADNI database.
Procedure: Infinitome
All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
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.
Time frame: Baseline
Correlation of Clinical Measures and Functional Connectivity Scores
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: 1. Caudate R/Substantia Nigra R and Clock Drawing Test 2. Caudate R/Substantia Nigra R and ADAS Number Cancellation 3. PH R/FST R and ADAS Construction Praxis 4. PH R/FST R and Clock Drawing Test
Time frame: Baseline
| Milestone | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) |
|---|---|---|---|
| Started | 19 | 36 | 36 |
| Completed | 18 | 36 | 36 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Unable to data match | 1 | 0 | 0 |
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.
| connectivity score | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) |
|---|---|---|---|
| PH_right and FST_left | 0.164 ± 0.008 | 0.374 ± 0.006 | 0.344 ± 0.006 |
| PH_right and FST_right | 0.340 ± 0.010 | 0.517 ± 0.006 | 0.442 ± 0.005 |
| PH_all and FST_left | 0.307 ± 0.009 | 0.456 ± 0.006 | 0.433 ± 0.006 |
| PH_all and FST_right | 0.359 ± 0.011 | 0.530 ± 0.005 | 0.493 ± 0.005 |
| SubNigComp_left and Caud_left | 0.124 ± 0.012 | 0.122 ± 0.005 | 0.132 ± 0.004 |
| SubNigComp_left and Caud_right | 0.134 ± 0.006 | 0.112 ± 0.005 | 0.144 ± 0.005 |
| SubNigComp_right and Caud_left | 0.088 ± 0.012 | 0.127 ± 0.003 | 0.130 ± 0.004 |
| SubNigComp_right and Caud_right | 0.063 ± 0.01 | 0.123 ± 0.004 | 0.123 ± 0.004 |
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: 1. Caudate R/Substantia Nigra R and Clock Drawing Test 2. Caudate R/Substantia Nigra R and ADAS Number Cancellation 3. PH R/FST R and ADAS Construction Praxis 4. PH R/FST R and Clock Drawing Test
| correlation coefficient | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) |
|---|---|---|---|
| Caudate R/Substantia Nigra R and Clock Drawing Test | -0.50 | -0.23 | 0.26 |
| Caudate R/Substantia Nigra R and ADAS Number Cancellation | -0.65 | -0.01 | -0.06 |
| PH R/FST R and ADAS Construction Praxis | -0.31 | -0.05 | -0.02 |
| PH R/FST R and Clock Drawing Test | -0.17 | 0.18 | -0.03 |
Collected over 2 months for DLB patients, No adverse event data collected for AD or CN patients.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With DLB | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Patients With Alzheimer's Disease (AD) | — | — | — |
| Patients With Normal Cognition (CN) | — | — | — |
| Age, Continuous(years) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| Mean | 75 ± 6.6 | 76 ± 7.3 | 74 ± 6.3 | 75 ± 6.7 |
| Sex: Female, Male(Participants) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| Female | 15 | 15 | 11 | 41 |
| Male | 3 | 21 | 25 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 4 | 5 |
| Not Hispanic or Latino | 18 | 35 | 32 | 85 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 6 | 8 |
| White | 18 | 32 | 29 | 79 |
| More than one race | 0 | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Education years(years) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| Mean | 17 ± 4 | 16 ± 3.6 | 16 ± .99 | 16 ± 4.1 |
| Mini-Mental State Examination (MMSE)(units on a scale) | Patients With DLB | Patients With Alzheimer's Disease (AD) | Patients With Normal Cognition (CN) | Total |
|---|---|---|---|---|
| Mean | 23 ± 2.2 | 23 ± 2.6 | 29 ± 2.6 | 26 ± 2.5 |
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