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Alzheimer's Imaging Consortium.

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Summary
This summary is machine-generated.

Task-based functional Magnetic Resonance Imaging (tb-fMRI) is viable for multi-center trials, even with varied equipment. Standardizing training enables novice sites to generate analyzable brain activation data for Alzheimer's disease research.

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Area of Science:

  • Neuroimaging
  • Clinical Trials
  • Alzheimer's Disease Research

Background:

  • Task-based functional Magnetic Resonance Imaging (tb-fMRI) measures brain activity via blood oxygenation.
  • Standardizing tb-fMRI equipment is crucial for multi-center clinical trials.
  • The TRAILBLAZER-ALZ 6 study investigated donanemab in early symptomatic Alzheimer's Disease (AD).

Purpose of the Study:

  • To implement and characterize visual task-based brain activation in a large, multi-center Phase 3b clinical trial.
  • To assess the feasibility of tb-fMRI as an exploratory measurement in the TRAILBLAZER-ALZ 6 study.
  • To evaluate brain activation in early symptomatic AD patients with confirmed amyloid pathology.

Main Methods:

  • 41 3 Tesla scanners were qualified, with 9 sites having established hardware and 32 sites using de novo setups with provided projectors.
  • A 4-minute visual task (alternating flashing annulus and crosshair) was administered.
  • fMRI data was acquired using a GRE-EPI sequence, pre-processed, normalized, and analyzed using a general linear model (GLM) with outlier regression.

Main Results:

  • Task-based fMRI data was successfully acquired from 799 participants.
  • Significant brain activation (mean T-score and BOLD contrast) was observed across all participants.
  • Participants at established sites showed significantly higher BOLD contrast values compared to de novo sites, though T-scores did not differ significantly.

Conclusions:

  • Task-based fMRI is a viable neuroimaging technique for multi-center clinical trials.
  • Novice sites can be effectively trained to use basic components and produce analyzable tb-fMRI data.
  • Variations in fMRI equipment primarily affect the magnitude, not the significance, of observed brain activation.