At the virtual American Academy of Neurology (AAN) conference on 17 to 22 April, US-based neurotechnology company nQ Medical presented preliminary data from its Phase II proof-of-concept (PoC) study named COBRE, the aim of which was to explore cognitive impairment in mild-moderate patients with Alzheimer’s disease (AD) through a set of four in-clinic typing and touchscreen tasks. The tasks were assessed using the digital biomarker nQi cog and its own technology platform known as neuroQWERTY (nQ). nQ depends on machine learning algorithms that interpret the data derived from the mechanical keyboard typing and use of touchscreen devices into meaningful metrics that can be applied in clinical diagnosis and assessment.
The initial COBRE cohort data collected from 120 patients over five years showed that the nQ technology identified the level of cognitive impairment in patients with Alzheimer’s compared to normal participants, on a par with the traditional non-digital assessments such as mini-mental state examination (MMSE) and Montreal cognitive assessment (MOCA). Encouragingly, some early signs suggest a correlation between the performance of the nQi cog biomarker and amyloid positron emission tomography (PET), an established imaging biomarker. This will be the most anticipated outcome of the study when the final results are published. The company received a breakthrough device designation for its nQ technology software application in Parkinson’s disease and therefore it is exploring different applications of its technology in the neurodegenerative space.
According to key opinion leaders (KOLs), key unmet needs remain for simple, inexpensive and non-invasive biomarkers that could be applied in the early diagnosis of AD due to the limitations of the current clinical biomarkers. An example is amyloid imaging, which was the comparator used in the nQ study and is one of the furthest developed biomarkers for AD that can be used to identify patients in the pre-dementia phase of AD or to support a diagnosis of AD in symptomatic patients. However, it needs to be performed in a clinical setting and it is expensive. Additionally, cerebrospinal fluid (CSF) testing is highly invasive as that must be collected via lumbar puncture.
As such, GlobalData expects that digital biomarkers such as the ones developed by nQ Medical have a good opportunity to emerge in the future, particularly after advances in digital health innovation were accelerated by the Covid-19 pandemic. Digital biomarkers have the potential to improve passive and remote monitoring of patients and evaluate patients continuously in the real world, as opposed to a clinical setting, in addition to being non-invasive.
Nevertheless, there have often been challenges in adopting new technology like digital biomarkers. This has largely been due to the initial high cost of shifting and the issues related to the privacy and security of patients’ data. Given that, nQ digital biomarkers need to prove that they are effective and reliable in filling a major gap in the current AD space such as the early detection of the disease. This will incentivise physicians to integrate these novel tools gradually into their research and clinical practice.
The company is planning to extend the study remotely, where passive data on the patients’ performance in remote typing will be collected directly from their smartphones. An independent cohort is expected to be enrolled into an extension of the study to evaluate the nQ technology in predicting the diagnosis of AD using blinded remote typing data.
GlobalData anticipates that, in the future, digital biomarkers for neurodegenerative diseases will likely be used in a multidisciplinary model that incorporates remote assessments with laboratory testing and gradual shifting will be more applicable to this space rather than a rapid disruption.