Highlights
- CHDR has extensive experience testing novel CNS compounds in early-phase clinical trials involving both healthy volunteers and patients.
- NeuroCart®, a comprehensive neurological and psychological test battery developed at CHDR, is used to link pharmacological mechanisms to relevant functional CNS domains.
- Validated pharmacological challenge tests can be used to demonstrate specific CNS effects in healthy subjects.
- Additional applications include neuroimaging techniques such as resting-state fMRI and PET, which are used to confirm that the relevant targets and/or networks are reached.
Summary
A powerful example of our combined neurophysiological and phenomenological approach is NeuroCart®. NeuroCart is used to characterise the pharmacological effects of compounds on a wide range of neurophysiological and neuropsychological functions in both healthy subjects and patients. It can also be used to measure functional diagnostic processes in psychopathology. Complementing this dynamic approach is our highly efficient recruitment strategy, which facilitates the recruitment of patient cohorts with various psychiatric conditions. In studies involving psychiatric patients, we place importance on close collaboration with the patients’ own healthcare professionals in order to ensure continuity of care.
Taking care of patients
Using the information obtained in early-phase clinical studies, researchers can design patient studies that are both safe and clinically relevant. CHDR has performed many trials in patient cohorts with a wide range of psychiatric disorders, and patient care is always the highest priority. When recruiting patients and obtaining informed consent, CHDR complies with the highest medical ethical standards. Patient safety and well-being are ensured by providing detailed information to the patient’s general practitioner and the attending psychiatrist throughout all stages of the study process.
Ready-for-Research
CHDR has also developed an innovative approach to recruiting patients: Ready-for-Research. Ready-for-Research means that we recruit and pre-screen patients who are interested in participating in future studies, including establishing their baseline CNS functions using NeuroCart®. With this approach, we can ensure that when a specific study is ready to begin, there is already a suitable patient cohort on hand. Using both functional and ‘wet’ biomarkers, we can also quantify systems that are relevant to the specific disease. For example, we can already perform an observational trial before the clinical study is even ready by measuring the hypothalamus-pituitary-adrenal axis and pro-inflammatory cytokines.
Practical answers to important research questions
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Does our compound have the desired effect?
Our combined approach allows CHDR researchers to assess whether novel compounds have the desired effect on CNS function. For example, to study a selective new GABAA α2α3 receptor agonist developed for treating anxiety disorders, CHDR researchers used NeuroCart® and found that the compound likely has anxiolytic effects in patients.
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What is the optimal dose for testing our compound in patients?
In studying a selective new GABAA α2α3 receptor agonist developed for treating anxiety disorders, the results of our early-stage clinical studies enabled us to determine the optimal pharmacologically active dose for future trials in patients with anxiety disorders.
CHDR has also played a central role in developing a rapidly dissociating dopamine receptor D2 antagonist. Researchers used a NeuroCart® test to measure D2 receptor antagonism, thereby estimating the optimal oral dose for maximum D2 receptor occupancy.
