Feasibility of Utilizing the Infinitome Program to Evaluate Abnormal Large Scale Brain Networks in Alzheimer’s Disease
2020 OCT 13 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT04563767 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Actual Start Date | |
| Current Primary Outcome Measures | •Rate of completion of rs-fMRI [ Time Frame: 4 months ] -- Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion. |
| •Rate of completed Analysis [ Time Frame: 4 months ] -- Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion. | |
| Current Secondary Outcome Measures | Not Provided |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT04563767 |
Descriptive Information
| Brief Title | Feasibility - Infinitome |
| Official Title | Feasibility of Utilizing the Infinitome Program to Evaluate Abnormal Large Scale Brain Networks in Alzheimer’s Disease |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | Not Provided |
| Study Design | Observational Model: Case-Only |
| Time Perspective: Cross-Sectional | |
| Condition | Alzheimer Disease |
| Intervention | •Procedure: Infinitome |
| Added sequence of rs-fMRI. | |
| Study Arms | •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-fM | |
| Interventions: | |
| ⚬Procedure: Infinitome |
Recruitment Information
| Recruitment Status | Enrolling by invitation |
| Estimated Enrollment | 4 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Inclusion Criteria: 1. Patients with a diagnosis of mild, moderate, or severe Alzheimer’s disease 2. Age: 40 |
| •90 Years 3. Patients who are clinically indicated for an MRI Exclusion Criteria: 1. fMRI contraindicated (eg. Implantable device, pacemaker, metallic implants, etc.) 2. Subject unable to tolerate sitting for a one hour fMRI 3. Other concerns as determined by the investigator | |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 40 years to 90 years |
| No | |
| Contacts | Contact information is only displayed when the study is recruiting subjects |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT04563767 |
| Other Study ID Numbers | A20-199 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | Not Provided |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: |
| Information Provided By | |
| Verification Date |
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