Phase II Alzheimer's Amyloid PET and MRI

Challenge

In a Phase II Alzheimer's disease program, the trial's biomarker endpoints depended on detecting subtle changes in brain volume and amyloid burden over time. Yet the 55 participating academic and commercial imaging centers operated scanners from multiple vendors, each introducing its own measurement variability into volumetric MRI quantification and amyloid PET assessment. Left uncontrolled, this cross-site noise threatened to obscure the very treatment effects the study was designed to detect, undermining both the secondary and exploratory biomarker endpoints.

Our Solution

Intrinsic Imaging implemented phantom-based site qualification to characterize and calibrate each scanner before a single subject was imaged, and every subsequent submission was automatically verified against the prescribed acquisition parameters. Central assessment paired quantitative volumetric analysis of regional atrophy with standardized visual PET scoring performed by trained readers, ensuring that both the quantitative and qualitative endpoints were derived under uniform, controlled conditions across all vendors and sites.

Results

• Cross-site measurement variation reduced by 38%
• Reliable secondary and exploratory biomarker endpoints
• Comparable imaging data across scanner vendors