Comprehensive Biomarker Testing for
Global Alzheimer’s Disease Trials
A Trusted Central Laboratory Partner for Biomarker-Driven Clinical Development
MLM Medical Labs delivers comprehensive central and specialty laboratory services for global Alzheimer’s disease clinical trials. With more than 30 years of experience, we provide high-quality biomarker testing, global logistics, and scientific expertise to generate consistent, reliable data across every phase of development.
Advancing Alzheimer’s Research. Enabling Confident Decisions.
Scientific Expertise and Operational Excellence
Our integrated central and specialty lab model brings biomarker testing, sample management, and data generation together under one roof—ensuring harmonization across sites, platforms, and regions while minimizing variability.
Comprehensive Biomarker Portfolio
MLM offers a broad Alzheimer’s disease biomarker portfolio across CSF and plasma matrices, including amyloid, tau, neurodegeneration, and neuroinflammation markers. Assays are selected and validated using a fit-for-purpose approach aligned with study objectives.
Global Reach with Operational Control
With wholly owned laboratories in North America, Europe, and Africa, supported by a carefully vetted network across 100+ countries, MLM ensures consistent, high-quality data generation. Harmonized processes and centralized oversight support reliable global trial execution.
Data You Can Trust
Operating under CAP, CLIA, and ISO-certified environments, MLM delivers high-quality, reproducible data to support critical trial decisions. Our capabilities empower sponsors to:
- Implement harmonized biomarker strategies
- Ensure consistency across regions and sites
- Adapt to evolving scientific and regulatory needs
Flexible Assay Development and Validation
As a Health Institution under EU IVDR, MLM is authorized to develop and validate Laboratory Developed Tests (LDTs) for clinical research – enabling flexible, regulatory-compliant incorporation of exploratory biomarkers in global trials.
The MLM Advantage
MLM combines scientific expertise, a comprehensive Alzheimer’s biomarker portfolio, and globally harmonized operations to support biomarker-driven trials. With integrated capabilities and fit-for-purpose strategies, MLM is a trusted partner for advancing Alzheimer’s disease therapeutic development.
Available Biomarkers & Platforms
Our Alzheimer’s disease biomarker capabilities support key clinical trial applications, including patient stratification, inclusion/exclusion, longitudinal monitoring, and pharmacodynamic assessment. Assays are implemented using harmonized platforms and a fit-for-purpose approach aligned with study objectives to ensure consistent, reliable data across global sites.
Need additional exploratory assays?
We support assay qualification and validation to meet your study’s specific needs.
Connect With MLM Medical Labs Today
Reach out to our team to learn how our scientifically validated, regulatory-compliant solutions can advance your global Alzheimer’s disease trial.
Overview of Biomarkers in Neurodegenerative Disease
Biomarkers are measurable indicators of biological conditions. In neurodegenerative diseases, they reflect changes such as amyloid-beta accumulation, tau pathology, and neuronal loss.
Cerebrospinal Fluid (CSF) Biomarkers
■ Amyloid-beta 42 (Aβ42): Decreased CSF levels indicate plaque formation in the brain.
■ Total Tau (t-tau): Elevated levels suggest neuronal damage and neurodegeneration.
■ Phosphorylated Tau (p-tau): Increased levels reflect Alzheimer’s-specific neurofibrillary tangles.
Blood Biomarkers
■ Plasma Tau (p-tau181, p-tau217, p-tau231): Elevated levels correlate with tau pathology in AD.
■ Neurofilament Light Chain (NfL): Indicates axonal damage and neuronal loss.
Plasma p-tau217: A Transformative Biomarker
Recent studies highlight plasma p-tau217 as one of the most promising biomarkers for Alzheimer’s disease, demonstrating high sensitivity and specificity for detecting pathology — even in early stages.
Key Advantages:
■ Differentiates Alzheimer’s from other dementias with high accuracy
■ Strong correlation with amyloid and tau pathology confirmed by PET and CSF
■ Detectable in preclinical and early symptomatic stages
■ Non-invasive and scalable for clinical trial deployment
Clinical Trial Applications:
■ Screening and enrolling participants with early Alzheimer’s pathology
■ Monitoring disease progression
■ Potential surrogate endpoint for treatment efficacy