In the realm of Central Nervous System (CNS) clinical trials, the expertise in science and technology is constantly being pushed to new boundaries. This case study focuses on a groundbreaking collaboration between a biotechnology company and its development partners, Clinilabs and IXICO, to conduct a complex Phase 1 multicenter, multi-arm Alzheimer’s disease (AD) clinical trial.

The goal was to generate rich data that would support the safety, tolerability, and potential efficacy of a new investigational drug aimed at treating Alzheimer’s disease.

The study was designed to assess the safety and tolerability of single and multiple doses of a monoclonal antibody investigational drug and to estimate its serum pharmacokinetics (PK) following intravenous (IV) administration in patients diagnosed with Alzheimer’s disease. The inclusion of AD patients necessitated a strategic approach involving specialty investigator sites with access to the patient population and the capability to perform complex biomarker assessments.

As a global, full-service CRO dedicated to the development of CNS therapeutics, Clinilabs’ project team identified high performing investigator sites and best-in-class providers to conduct the study.

IXICO was selected to participate because of its neurological imaging expertise, and its leadership in brain imaging. MRI scans on this trial were centrally read by neuroradiologists and used to monitor the occurrence and progression of Amyloid Related Imaging Abnormalities (ARIA). Detection and management of ARIA was critical to ensuring diagnostic accuracy and the success of the trial.

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