Your Imaging Analysis & Operations Experts in Alzheimer’s Disease Clinical Research
IXICO’s Alzheimer’s Disease Footprint at a Glance
Pioneering Precision in AD Imaging
IXICO excels in AD imaging with advanced imaging biomarkers to quantify markers such as amyloid plaques, tau tangles, and brain atrophy. Our AI-driven IXIQ.Ai platform enhances the accuracy and efficiency of brain imagine measurements. We have supported over 20,000 brain scans collected through various AD research initiatives, driving innovation and harmonizing imaging data for better clinical trial outcomes.
Seamless Global Imaging Solutions
We offer comprehensive imaging support with global site management, a regulatory-compliant platform and processes, and rapid Amyloid and Tau PET eligibility read reports within three days. Our services include centralized radiology reads, AD-specific workflows, advanced analytics, and tailored solutions to meet diverse clinical trial needs, ensuring seamless data collection and analysis.
Proven Excellence in AD Clinical Trials
With over 25 sponsors supported across 55 clinical studies, IXICO collaborates with leading institutions and initiatives like ADNI, GAP, AMYPAD and EPAD to name a few. Our proven expertise ensures high-quality deliverables and successful trial outcomes, making us a trusted partner in advancing AD research and clinical trials.
Key Imaging Biomarkers
Key imaging biomarkers, such as Amyloid PET, Tau PET, and volumetric MRI, are crucial for accurately diagnosing and monitoring Alzheimer's disease. These biomarkers are essential for safety monitoring, eligibility, and assessing drug efficacy.
They provide critical insights into disease progression, enabling researchers to make informed decisions in clinical trials. Our centralized radiology reads ensure consistent and high-quality evaluations across all imaging data. By quantifying amyloid plaques, tau tangles, and structural brain changes, these biomarkers help identify patients at various stages of the disease, ultimately guiding therapeutic strategies and improving patient outcomes.
Our well-defined process to address discrepancies between local and central reads, minimizing delays in trial enrolment with our robust discordance resolution workflow. Our tailored radiological read solutions allow for customizable read reports and reading paradigms to meet the specific needs of each clinical trial, such as single, dual, consensus or adjudication workflows.
Centralised radiology reading outcomes in Alzheimer’s Disease (AD)
- Centralized MRI Eligibility Reads:
- Importance: Conducted by our expert neuroradiologists with expertise in diagnostic imaging and identification of comorbidities.
- Service: Reviewing Study MRI-related exclusion criteria at screening.
- Centralized MRI Safety Reads:
- Importance: Conducted by our expert neuroradiologists with expertise in clinical trial safety monitoring and particularly ARIA-E and ARIA-H monitoring.
- Service: Review of presence, number and location of new or changed findings such as ARIA-E, microhaemorrhages, macrohaemorrhages, and superficial siderosis.
- Centralised Amyloid PET Reads:
- Importance: Conducted by expert nuclear medicine physicians to support eligibility decisions.
- Service: Read can be performed as a visual only read and/or a VisQ read (where reader is provided with supporting SUVr information) to visually determine Amyloid classification.
- Centralised Tau PET Reads:
- Importance: Conducted by expert nuclear medicine physicians to support eligibility decisions.
- Service: Read workflow and criteria are tailored to specific Tau tracer(s) in use to visually determine Tau classification.
Quantitative Imaging Endpoints in Alzheimer’s Disease (AD)
- Amyloid PET
- Importance: Essential for determining eligibility and longitudinal analysis for monitoring disease progression and target engagement by visualizing amyloid plaques.
- Imaging Analysis:
- SUVR: Quantifies amyloid burden.
- Centiloid Scale: Standardizes results across different tracers
- Tau PET
- Importance: Provides insights into tau tangles to monitor disease progression and target engagement, correlating with cognitive decline.
- Imaging Analysis:
- SUVR: Quantifies tau pathology.
- Structural MRI
- Importance: Assesses structural changes, particularly in the hippocampus.
- Imaging Analysis:
- Volumetric Analysis: Measures brain regional atrophy.
- Vascular pathology
- Importance: Assesses vascular pathology changes due to ageing or comorbidities
- Imaging Analysis:
- White Matter Hyperintensity: Measures white matter hyperintensity volume, a marker of neuroinflammation and cerebral small vessel disease
- ASL (Arterial Spin Labelling) MRI
- Importance: Measures tissue perfusion (cerebral blood flow).
- Imaging Analysis:
- Regional CBF Measurement: Quantifies tissue perfusion (e.g. hypoperfusion) in brain regions.
- Diffusion MRI:
- Importance: Evaluates white and grey matter tissue microstructural integrity and connectivity.
- Imaging Analysis:
- Diffusion Tensor Imaging (DTI): Assesses microstructural integrity of grey and white matter tissue.
- Neurite Orientation Dispersion and Density Imaging (NODDI): Multi-compartment model to provide further detail on microstructural tissue integrity.
- Free Water Imaging (FWI): Multi-compartment model used to quantify changes in intra- and extra-cellular water, which could be due neuroinflammation.
- Structural Connectivity: Measures loss of white matter pathways due to neurodegeneration
- Functional MRI:
- Resting-State fMRI (rs-fMRI): Measures altered functional connectivity patterns due to re-organisation and neurodegeneration
- QSM (Quantitative Susceptibility Mapping)
- Importance: Provides insights into iron deposition by quantifying magnetic susceptibility in brain tissue, which can be altered in Alzheimer's disease.
- Imaging Analysis:
- Susceptibility Mapping: Quantifies magnetic susceptibility, an indicator of inflammation and neurodegeneration.
PET Tracer Management & Coordination
Our Tracer Management services oversee the provision of Amyloid and Tau PET tracers to the sites and covers the following:
- Contracting for supply and transportation
- Supply invoice reconciliation and passthrough financial administration
- Imaging site onboarding and training for tracer supply ordering and handling
- Ongoing tracer coordination management oversight and supply monitoring
Advanced Analytics and Technology
Our advanced analytics capabilities are designed to enhance trial outcomes:
- AI-Driven Analysis: We employ sophisticated AI pipelines for quantifying imaging endpoints, ensuring rapid and accurate results.
- TrialTracker™ Platform: A GCP and 21 CFR compliant infrastructure that centralizes imaging data, streamlining the workflow from image acquisition to reporting.
Comprehensive Imaging Support
- End-to-End Services: IXICO delivers complete clinical imaging support for neurological diseases, collaborating with specialty biotech firms, CROs, and top pharmaceutical companies.
- Global Site Support: Our extensive network of sites across multiple countries ensures that we can efficiently manage and support clinical trials worldwide. We have the operational capacity to onboard and manage 100s of sites, facilitating seamless data collection and analysis across diverse geographies.
In collaboration with the wider Alzheimer’s Disease Network
- Global Alzheimer’s Program (GAP): Supporting the Bio-Hermes 001 and 002 trials to develop a comprehensive biomarker database.
- Alzheimer's Disease Neuroimaging Initiative (ADNI): Contributing to the development of clinical and imaging biomarkers, where extensive data access allows for development and validation of our cutting-edge analysis methodologies.
- AMYPAD and EPAD: Enhancing understanding of early-stage AD and prevention strategies through collaborative research.
Key Contributions in AD Research
- Extensive Experience: Over 25 sponsors supported across 55 AD clinical studies, with more than 20,000 brain scans analysed globally.
- Rapid Turnaround: Average turnaround time of three days for PET reads, ensuring timely results for trial progression.
- Global Reach: A network of 2,000+ imaging sites across 50+ countries, facilitating diverse and inclusive clinical trials.
Proven Track Record
IXICO has established a strong reputation in AD research:
- Expert Team: Our central reading team comprises of leading neuroradiologists such as Prof Frederik Barkhof for MRI and Dr Elsmarieke van de Giessen for PET, ensuring high-quality assessments and compliance with regulatory standards.
Why Choose IXICO?
Choosing IXICO means partnering with a leader in neuroimaging for Alzheimer’s disease:
- Expertise: Deep knowledge of AD biomarkers and imaging techniques, backed by a proven track record.
- Innovation: Commitment to advancing imaging methodologies through ongoing research and development.
- Collaboration: Strong ties with academic and industry leaders, fostering a collaborative approach to tackling the challenges of AD research.
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