Solutions and capabilities
Dedication to biomarker development
At CHDR, we understand the critical role of integrating relevant biomarkers in clinical development programmes right from the start. Biomarkers are essential in the early stages of drug development, enabling us to evaluate the pharmacological activity of a drug and determine the optimal dose for investigation in patients. To facilitate the exploration of a broad range of mechanisms and effects, we offer a diverse range of methods and tools:
NeuroCart®, a comprehensive neurophysiological and neurocognitive test batteryÂ
Electroencephalography (EEG), including resting-state EEG recordings as part of the NeuroCart® test battery, as well as task-related EEG tools offering markers of stimulus or information processing
Measures of cortical, neuronal and muscle excitability, such as Transcranial Magnetic Stimulation (TMS) coupled with electromyography (EMG) and electroencephalography (EEG), excitability threshold tracking of peripheral nerves, and muscle velocity recovery cycles (MVRCs)
Pharmacological challenge models, such as a scopolamine or mecamylamine challenge to induce a temporary decrease in cognitive performance to test cholinergic drugs
Cerebrospinal fluid (CSF) sampling, through (multiple) lumbar punctures
Blood sampling, potentially including ex vivo challenges, to provide blood-based biomarkers for the measurement of effects on molecular pathways
Advanced imaging, including (f)MRI and PET scans, magnetic resonance (MR) spectroscopy and mitochondrial function measurements
Developing a drug for Parkinson’s disease: from biomarker validation to healthy volunteer and patient studies
CHDR was tasked with conducting a single and multiple ascending dose study in both healthy volunteers and 40 patients with Parkinson’s disease (PD) carrying a GBA1 gene mutation, which occurs in only 5 –10% of PD patients. To support this, we initiated a genetic screening study involving over 3,400 PD patients across the Netherlands, providing the foundation for a proof-of-concept study in this specific patient population.
Simultaneously, a phase 0 biomarker study was carried out in both healthy volunteers and PD patients to assess the within-day and day-to-day within-subject and between-subject variability of biomarkers. The single and multiple ascending dose study in healthy volunteers was conducted first to determine the optimal dose for the subsequent patient study. This patient study was then performed with subjects selected based on the genetic screening results.
This complex, multifaceted development programme was completed within a highly competitive timeline, with the entire project wrapped up within 16 months of the first trial's initiation.
