Feasibility - Infinitome

Feasibility of Utilizing the Infinitome Program to Evaluate Abnormal Large Scale Brain Networks in Alzheimer's Disease

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Procedure: Infinitome

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for Alzheimer's disease.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Infinitome; Added sequence of rs-fMRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2020
• Primary Completion (ACTUAL): October 13, 2020
• Study Completion (ACTUAL): October 13, 2020

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (ACTUAL): September 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: A20-199