Feasibility - Infinitome

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563767
• Other study ID #: A20-199
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: October 13, 2020

Study information

• Verified date: September 2020
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Procedure:
• Infinitome
Added sequence of rs-fMRI.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 months
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.	4 months