Actinogen Medical Limited is expanding its collaboration with Cambridge Cognition Holdings plc to enhance the Phase 2b/3 XanaMIA trial for Alzheimer’s disease. This expansion builds upon the successful integration of Cambridge Cognition’s digital tools in the initial phase of the study, reinforcing the commitment to precise clinical measurements.
The XanaMIA trial is a Phase 2b/3 study involving 220 patients diagnosed with mild to moderate dementia due to Alzheimer’s disease, all of whom exhibit elevated levels of the plasma biomarker pTau181. Participants in the trial will receive either emestedastat (Xanamem) at a dosage of 10 mg or a placebo, administered once daily over a 36-week period. The primary objective is to evaluate emestedastat’s potential in slowing the progression of Alzheimer's disease.
The trial's primary endpoint is the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB), supported by Cambridge Cognition. Secondary cognitive endpoints include Cambridge Cognition’s CANTAB (Cambridge Neuropsychological Test Automated Battery) for attention and working memory assessment, along with AQUA, an automated quality assurance solution. These tools are designed to ensure greater comparability and superior data quality throughout Actinogen’s clinical development program.
Digital Tools for Enhanced Data Quality
Cambridge Cognition’s integrated platform offers a suite of digital solutions, including Cognitive Assessments (CANTAB), electronic Clinical Outcome Assessments (eCOA), and automated quality assurance (AQUA). These tools are pivotal in ensuring the reliability and validity of the data collected during the trial.
Rob Baker, Joint Managing Director and Chief Operating Officer at Cambridge Cognition, stated, “We are proud to deepen our collaboration with Actinogen in their important work in Alzheimer’s research. This partnership highlights the value of our integrated platform in advancing innovative studies.”
Commitment to Advancing Alzheimer's Research
With dementia affecting an estimated 47 million individuals globally, and projections indicating a rise to 75 million by 2030, the need for effective therapies is critical. Actinogen is focused on developing therapies that control elevated brain cortisol levels, aiming to slow or halt the progression of neurological diseases.
Dr. Steven Gourlay, Actinogen’s CEO and MD, commented, “Actinogen’s commitment to advancing Alzheimer's research demands robust and reliable data collection. Cambridge Cognition's integrated platform – combining CANTAB, eCOA, and AQUA – provides us with validated cognitive assessments and high-quality endpoint measurements that are crucial for evaluating the therapeutic benefits of emestedastat. This comprehensive solution strengthens our confidence in the data integrity for our XanaMIA trial.”
