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The Infinitome Program from Omniscient has the ability to identify abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI). This technology, which visualizes brain networks in three dimensions, was originally developed to ensure neurosurgeons avoid inadvertently lesioning cognitively eloquent brain regions during surgical operations. The potential of Infinitome in identifying connectome dysfunction for neurodegenerative diseases such as Alzheimer's disease has yet to be explored. This diagnostic technique may play a critical role for identifying disease brain networks that may benefit from targeted interventions in clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infinitome | All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infinitome | Procedure | Added sequence of rs-fMRI. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Rs-fMRI | Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion. | 4 months |
| Number of Subjects Whose Images Completed Analysis | Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for Alzheimer's disease.
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Rosenbloom, MD | HealthPartners Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infinitome | All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed. Infinitome: Added sequence of rs-fMRI. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infinitome | All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed. Infinitome: Added sequence of rs-fMRI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed Rs-fMRI | Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion. | Posted | Count of Participants | Participants | 4 months |
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Only observed during MRI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infinitome | All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed. Infinitome: Added sequence of rs-fMRI. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Rosenbloom, MD | HealthPartners Neurology | 651-495-6363 | michael.h.rosenbloom@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2020 | Feb 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Number of Subjects Whose Images Completed Analysis | Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion. | Posted | Count of Participants | Participants | 4 months |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |