Sponsors running AD biomarker clinical trials need imaging data they can trust at every phase, from screening participants against amyloid and tau status, to tracking disease progression, to monitoring for treatment-related safety signals. IXICO provides Alzheimer's disease neuroimaging and biomarker analysis built specifically for that workload: validated amyloid and tau PET quantification, structural MRI atrophy measurement, and centralised ARIA-H and ARIA-E safety monitoring, delivered by a team with two decades of CNS trial experience. All of this runs through one centralised imaging platform spanning MRI, PET and SPECT, so sponsors are never limited to a single-modality vendor.
Our imaging biomarkers have supported major AD research initiatives including Bio-Hermes, AMYPAD, ADNI, and EPAD, and our analysis pipelines are built to meet the regulatory scrutiny AD programmes require, from Phase 1 proof-of-concept through to pivotal registration trials. IXICO also plays a role in diagnostics, having contributed to the validation of a blood-based Alzheimer’s biomarker test that received first FDA clearance in 2025.
Alzheimer's disease is now recognised as biologically heterogeneous, with multiple interconnected drivers of disease progression rather than a single pathological pathway. Advances in blood-based biomarkers (BBBM) are enabling earlier enrolment and improved participant stratification, and the clinical development pipeline has diversified in response to this more nuanced understanding of disease biology. That shift means sponsors need imaging biomarkers that reflect it: measures that can help validate emerging biological signals, support exploration of treatment effects on underlying disease mechanisms, provide consistent safety monitoring, and deliver robust, regulatory-ready measures for large-scale studies.
IXICO's role is to remove that risk, providing standardised acquisition protocols, validated quantification methods, and audit-ready data packages so imaging never becomes the bottleneck.
| Modality | What it measures | Typical use in AD trials |
|---|---|---|
| Structural MRI Volumetric Biomarkers | Whole-brain and regional atrophy patterns, including ventricular enlargement, tracked over time | Longitudinal monitoring, regulatory endpoints, participant enrichment/stratification |
| Cerebrovascular Imaging Biomarkers | White matter lesions and cerebral microbleeds | Disease progression context, treatment-effect interpretation, safety monitoring, and eligibility screening (inclusion/exclusion) |
| Diffusion Microstructure Biomarkers | White matter microstructure and connectivity (free-water, DTI-ALPS, PSMD) | Monitoring microstructural change; neuroinflammation and glymphatic-function signals remain exploratory measures |
| MR Spectroscopy (MRS) | Metabolite concentrations (NAA, myo-inositol, choline, glutamate/Glx) | Early-phase studies targeting mitochondrial or metabolic pathways |
| Perfusion Biomarkers (ASL) | Regional cerebral blood flow | Assessing therapies targeting vascular or metabolic function |
| Amyloid PET Imaging | Amyloid plaque burden (SUVR, Centiloid) | Enrolment screening, participant enrichment, target engagement |
| Tau PET Imaging | Regional tau distribution and load | Disease staging, participant stratification, treatment response |
| FDG PET | Regional cerebral glucose metabolism | Pharmacodynamic effects, monitoring neurodegeneration, complementary biomarker context |
Provides sensitive, reproducible neurodegeneration measures for longitudinal AD trials and regulatory endpoints. Includes: DTI, Free water, DTI-ALPS, PSMD
Detects microstructural tissue changes that may precede atrophy and support monitoring. Includes: ASL, MRS, FDG-PET, fMRI, SPECT
Supports molecular imaging assessment where pathology, metabolism or target engagement are relevant. Includes: Amyloid, Tau and FDG PET
Identifies vascular contributors and safety considerations relevant to AD studies. Includes: Cerebrovascular imaging biomarkers - white matter lesion and cerebral microbleed quantification. This is an area of active R&D investment for IXICO as vascular contributions to Alzheimer's disease gain increasing research attention.
Multi-site AD trials depend on consistent tracer supply and handling. IXICO coordinates PET tracer logistics across sites, reducing variability that could otherwise affect biomarker read-outs.
IXICO's imaging biomarker analysis has supported some of the highest-profile studies in Alzheimer's research, including:
•Bio-Hermes - evaluating blood-based and imaging biomarkers to accelerate AD trial recruitment
•AMYPAD - one of the largest amyloid PET imaging programmes in Europe
•ADNI - the field's longest-running longitudinal AD biomarker study
•EPAD - a pan-European platform for early AD research
In 2025, IXICO's Bio-Hermes PET imaging data also supported the first FDA clearance of a blood-based Alzheimer's diagnostic biomarker, a strong, concrete proof point of IXICO's role at the leading edge of AD biomarker validation. Having done the first FDA clearance we are now working with other BBM companies to validate further AD diagnostic tests.
Biomarkers and imaging in Alzheimer’s disease: Understanding Amyloid and Tau within the ATN Framework
Imaging of Neurodegeneration within the NIA-AA Research Framework: The ‘N’ in the AT(N) Scheme
Why partnerships are the promising pathway for Alzheimer’s breakthroughs
Advancing AD Trials: Integrating Plasma Biomarkers and Imaging for Precision Enrolment
Imaging - Advancing Biomarker Research for Alzheimer’s Disease Diagnosis
Journal for Clinical Studies Issue 17 April 2025
Exploring how GLP-1 Drugs and vascular biomarkers are shaping Alzheimer’s Disease clinical trial design
AI-Driven Recruitment for Alzheimer’s Disease Clinical Trials: A Pilot Analysis on the A4 Dataset
> Imaging - Advancing Biomarker Research for Alzheimer’s Disease Diagnosis
The Potential of Blood-Based Biomarkers & Digital Assessments in Transforming Research and Clinical Practice
The most common are amyloid PET and tau PET for pathology confirmation and staging, and structural MRI for measuring brain atrophy over time. ARIA monitoring via MRI is also required for trials of amyloid-modifying therapies.
Imaging biomarkers provide objective, quantifiable evidence of disease pathology and progression, supporting both patient selection (screening for amyloid/tau positivity) and endpoint measurement, increasingly a regulatory expectation for AD drug approval.
ARIA (amyloid-related imaging abnormalities) covers two related safety signals seen with amyloid-targeting therapies: ARIA-E (oedema and effusion) and ARIA-H (microhaemorrhages, macrohaemorrhages, and superficial siderosis). Centralised MRI monitoring, read by experienced neuroradiologists with dedicated ARIA expertise, detects and grades both ARIA-E and ARIA-H consistently across trial sites, supporting participant safety oversight.
IXICO provides end-to-end imaging biomarker services – protocol design, PET/MRI quantification, ARIA safety monitoring, tracer coordination, and regulatory-ready data packages, drawing on experience across Bio-Hermes, AMYPAD, ADNI, and EPAD.
Ready to discuss imaging biomarkers for your AD trial? Talk to our neuroimaging team about protocol design, endpoint selection, or ARIA safety monitoring for your next Alzheimer's disease study.
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