# Alzheimer's Disease Biomarkers | IXICO

IXICO supports Alzheimer's disease clinical trials with precision neuroimaging and biomarker analysis. Accelerate AD drug development and diagnostics with our CNS expertise.

# Alzheimer's Disease (AD) Neuroimaging & Biomarker Analysis

![AD Left Dark](/assets/element-images/AD-Left-Dark__FitMaxWzk2MCw1NDBd_ExtRewriteWyJwbmciLCJ3ZWJwIl0.webp "AD Left Dark")

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](http://ixico.com/services/imaging-biomarkers/pet-and-spect), [structural MRI atrophy measurement](http://ixico.com/services/imaging-biomarkers/volumetric-mri), and [centralised ARIA-H and ARIA-E safety monitoring](http://ixico.com/services/post-marketing), delivered by a team with [two decades of CNS trial experience](http://ixico.com/company). All of this runs through [one centralised imaging platform](http://ixico.com/services/imaging-biomarkers) spanning MRI, PET and SPECT, so sponsors are never limited to a single-modality vendor.

Our imaging biomarkers have supported [major AD research initiatives](http://ixico.com/company/partnerships) 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](http://ixico.com/news-and-resources/downloads/executing-a-multi-arm-phase-1-alzheimers-disease-global-clinical-trial-with-clinilabs-and-ixico) 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.

##  Why Imaging Biomarkers Matter in Alzheimer's Disease Trials

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](http://ixico.com/services/imaging-biomarkers), and [audit-ready data packages](http://ixico.com/services/data-analytics) so imaging never becomes the bottleneck.

## Alzheimer's Disease Neuroimaging Services

ModalityWhat it measuresTypical use in AD trialsStructural MRI Volumetric BiomarkersWhole-brain and regional atrophy patterns, including ventricular enlargement, tracked over timeLongitudinal monitoring, regulatory endpoints, participant enrichment/stratificationCerebrovascular Imaging BiomarkersWhite matter lesions and cerebral microbleedsDisease progression context, treatment-effect interpretation, safety monitoring, and eligibility screening (inclusion/exclusion)Diffusion Microstructure BiomarkersWhite matter microstructure and connectivity (free-water, DTI-ALPS, PSMD)Monitoring microstructural change; neuroinflammation and glymphatic-function signals remain exploratory measuresMR Spectroscopy (MRS)Metabolite concentrations (NAA, myo-inositol, choline, glutamate/Glx)Early-phase studies targeting mitochondrial or metabolic pathwaysPerfusion Biomarkers (ASL)Regional cerebral blood flowAssessing therapies targeting vascular or metabolic functionAmyloid PET ImagingAmyloid plaque burden (SUVR, Centiloid)Enrolment screening, participant enrichment, target engagementTau PET ImagingRegional tau distribution and loadDisease staging, participant stratification, treatment responseFDG PETRegional cerebral glucose metabolismPharmacodynamic effects, monitoring neurodegeneration, complementary biomarker context

![Gradient](/gradients/gradient-right.png)

## Quantitative Imaging Endpoints

### Structural MRI Volumetric Biomarkers

Provides sensitive, reproducible neurodegeneration measures for longitudinal AD trials and regulatory endpoints. Includes: DTI, Free water, DTI-ALPS, PSMD

[    Advanced MRI ](/services/imaging-biomarkers/advanced-mri/?Advanced_MRI_Biomarker_Analytics_for_CNS_Trials=)

### Diffusion Microstructure Biomarkers

Detects microstructural tissue changes that may precede atrophy and support monitoring. Includes: ASL, MRS, FDG-PET, fMRI, SPECT

[    Advanced MRI ](/services/imaging-biomarkers/advanced-mri/?ASL%2C_MRS%2C_FDG-PET%2C_fMRI%2C_SPECT=#advanced-mri-biomarker-analytics-for-cns-trials)

### Molecular Imaging Biomarkers

Supports molecular imaging assessment where pathology, metabolism or target engagement are relevant. Includes: Amyloid, Tau and FDG PET

[    PET & SPECT Imaging ](/services/imaging-biomarkers/pet-and-spect/?Amyloid%2C_Tau_and_FDG_PET=#pet-and-spect-imaging)

### Vascular Imaging Biomarkers

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.

[    GLP-1 Drugs & Vascular biomarkers ](/news-and-resources/blog/exploring-how-glp-1-drugs-and-vascular-biomarkers-are-shaping-alzheimers-disease-clinical-trial-design/?Exploring_how_GLP-1_Drugs_and_vascular_biomarkers_are_shaping_Alzheimer%E2%80%99s_Disease_clinical_trial_design=#exploring-how-glp-1-drugs-and-vascular-biomarkers-are-shaping-alzheimers-disease-clinical-trial-design)

### PET Tracer Management & Coordination

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.

[    Trial Imaging ](/services/trial-management/?Multi-site_AD_trials=#clinical-trial-imaging-management)

##  Proven in the Field's Leading AD Initiatives

IXICO's imaging biomarker analysis has supported some of the highest-profile studies in Alzheimer's research, including:

•[Bio-Hermes](http://ixico.com/news-and-resources/news/ixico-and-global-alzheimers-platform-foundation-announces-strategic-collaboration-and-partnership-for-the-transformative-bio-hermes-002-study) - evaluating blood-based and imaging biomarkers to accelerate AD trial recruitment

•[AMYPAD](http://ixico.com/news-and-resources/publications/amyloid-pet-alzheimers-disease-amypad) - one of the largest amyloid PET imaging programmes in Europe

•[ADNI](http://ixico.com/company/partnerships) - the field's longest-running longitudinal AD biomarker study

•[EPAD](http://ixico.com/company/partnerships) - 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](https://ixico.com/news-and-resources/news/ixico-assists-first-fda-clearance-of-new-alzheimers-disease-blood-based-diagnostic-biomarker), 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.

![Gradient](/gradients/gradient-right.png)

## Alzheimer's Disease Content Portal

### Blog

Biomarkers and imaging in Alzheimer’s disease: Understanding Amyloid and Tau within the ATN Framework

[    View Here ](/news-and-resources/blog/biomarkers-and-imaging-in-alzheimers-disease-understanding-amyloid-and-tau-within-the-atn-framework/)

### Blog

Imaging of Neurodegeneration within the NIA-AA Research Framework: The ‘N’ in the AT(N) Scheme

[    View Here ](/news-and-resources/blog/imaging-of-neurodegeneration-within-the-nia-aa-research-framework-the-n-in-the-atn-scheme/)

### Blog

Why partnerships are the promising pathway for Alzheimer’s breakthroughs

[    View Here ](/news-and-resources/blog/why-partnerships-are-the-promising-pathway-for-alzheimers-breakthroughs/)

### Blog

Advancing AD Trials: Integrating Plasma Biomarkers and Imaging for Precision Enrolment

[    View Here ](/news-and-resources/blog/advancing-ad-trials-integrating-plasma-biomarkers-and-imaging-for-precision-enrolment/)

### Editorial

Imaging - Advancing Biomarker Research for Alzheimer’s Disease Diagnosis Journal for Clinical Studies Issue 17 April 2025

[    View Here ](/news-and-resources/blog/imagingadvancing-biomarker-research-for-alzheimers-disease-diagnosis/)

### Blog

Exploring how GLP-1 Drugs and vascular biomarkers are shaping Alzheimer’s Disease clinical trial design

[    View Here ](/news-and-resources/blog/exploring-how-glp-1-drugs-and-vascular-biomarkers-are-shaping-alzheimers-disease-clinical-trial-design/)

## Recent AD Scientific Publications

**AI-Driven Recruitment for Alzheimer’s Disease Clinical Trials: A Pilot Analysis on the A4 Dataset**

- **Date**: 28th July 2025
- **Presentation type:** Oral presentation at the Alzheimer’s Association International Conference 2025 in Toronto, Canada
- **Synopsis:** An MRI-based machine learning model, trained to classify dementia types, was evaluated as a pre-screening tool in Alzheimer’s disease trials using A4 Study data
- **Therapeutic Indication:** Alzheimer’s disease (AD)

[**> Imaging - Advancing Biomarker Research for Alzheimer’s Disease Diagnosis**](https://onlinelibrary.wiley.com/doi/full/10.1002/ana.27237)

- **Date:** April 17th 2025
- **Presentation type:** invited editorial in the Journal for Clinical Studies
- **Synopsis**: editorial discussion on the multimodal use of PET imaging in combination with novel blood-based biomarkers to support streamlined clinical trial delivery
- **Therapeutic Indication:** Alzheimer’s disease (AD)

[**> AI-Driven Classification of Alzheimer’s Disease and Frontotemporal Dementia from Magnetic Resonance Imaging**](https://onlinelibrary.wiley.com/doi/full/10.1002/ana.27237)

- **Date**: April 4th 2025
- **Presentation type:** oral presentation at the 40th International Conference on Alzheimer’s Disease and Parkinson’s Disease (ADPD) in Vienna, Austria
- **Synopsis:** development and validation of novel AI-driven measurements to support differential diagnosis between AD and FTD from volumetric MRI
- **Therapeutic Indication:** Alzheimer’s disease (AD); Frontotemporal dementia (FTD)

**The Potential of Blood-Based Biomarkers & Digital Assessments in Transforming Research and Clinical Practice**

- **Date:** February 26th 2025
- **Presentation type:** invited podium presentation and discussion at the GAP-Net **Site Optimization** Conference 2025
- **Synopsis:** invited presentation to discuss the critical role of imaging in an evolving AD biomarker landscape, specifically in combination with novel blood based biomarker tests. Joint panel with C-level experts from diagnostics and pharma companies.
- **Therapeutic Indication:** Alzheimer’s disease (AD)

[**> Quantification Supports Amyloid PET Visual Assessment of Challenging Cases: Results from the AMYPAD Diagnostic and Patient Management Study**](https://pubmed.ncbi.nlm.nih.gov/39288341/)

- **Date:** January 2025
- **Presentation type:** co-authored journal manuscript with the AMYPAD consortium in The Journal of Nuclear Medicine
- **Synopsis**: analysis of the AMYPAD study data that shows how automated quantitative analysis of amyloid PET data can support and streamline visual expert assessment.
- **Therapeutic Indication**: Alzheimer’s disease (AD)

[**> A multi-stage approach to screen Amyloid status using plasma p-Tau217 prior to confirmatory Imaging applied to the Bio-Hermes Trial**](https://pubmed.ncbi.nlm.nih.gov/39288341/)

- **Date**: October 31st 2024
- **Presentation type:** oral presentation at the 17th Clinical Trials in Alzheimer’s Disease (CTAD) conference in Madrid, Spain.
- **Synopsis**: analysis of the Global Alzheimer’s Platform Bio-Hermes data to investigate how blood-based biomarkers can be operationalised in conjunction with PET imaging.
- **Therapeutic Indication**: Alzheimer’s disease (AD)

[**> Association of Vascular Risk Factors and Cerebrovascular Pathology with Alzheimer's Disease Pathologic Changes in Individuals Without Dementia**](https://pubmed.ncbi.nlm.nih.gov/39288341/)

- **Date:** October 8th  2024
- **Presentation type:** co-authored journal manuscript with the AMYPAD consortium in the journal Neurology
- **Synopsis:** investigation of links between vascular risk factors, cerebral small vessel disease, and amyloid levels and their combined effect on downstream AD biomarkers.
- **Therapeutic Indication:** Alzheimer’s disease (AD)

## Frequently Asked Questions

### What imaging biomarkers are used in Alzheimer's disease clinical trials?

The most common are [amyloid PET and tau PET](https://ixico.com/services/imaging-biomarkers/pet-and-spect) for pathology confirmation and staging, and [structural MRI](https://ixico.com/services/imaging-biomarkers/volumetric-mri) for measuring brain atrophy over time. [ARIA monitoring via MRI](https://ixico.com/services/post-marketing) is also required for trials of amyloid-modifying therapies.

### Why is neuroimaging important for AD biomarker clinical trials?

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.

### What is ARIA and why does it need to be monitored?

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.

### How does IXICO support AD biomarker clinical trials?

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](https://ixico.com/company/partnerships).

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.

**[Contact us](http://ixico.com/contact-us)  \|  [Download the AD Quick Guide](http://ixico.com/assets/downloads/IXICO-A-Quick-Guide-to-Imaging-Analysis-Operations-Essentials-in-Alzheimers-Disease-Clinical-Research-June-2025.pdf)  \|  [Speak to a specialist](http://ixico.com/contact-us/submit-rfp)  \|  [View AD case studies](http://ixico.com/news-and-resources/downloads/executing-a-multi-arm-phase-1-alzheimers-disease-global-clinical-trial-with-clinilabs-and-ixico)  \|  [View our AD imaging webinar](https://ixico.com/news-and-resources/webinars/using-ai-to-optimize-tau-pet-imaging-for-alzheimers-disease-clinical-development)**