Alzheimer Disease
Conditions
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.
Interventions
PROCEDUREInfinitome
Added sequence of rs-fMRI.
Sponsors
HealthPartners Institute
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Rs-fMRI | 4 months | Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion. |
| Number of Subjects Whose Images Completed Analysis | 4 months | Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Infinitome | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infinitome | Number of Participants Who Completed Rs-fMRI | 4 Participants |
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.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infinitome | Number of Subjects Whose Images Completed Analysis | 4 Participants |