The FDA have released guidance urging clinical trials to go virtual where possible in response to the COVID-19 pandemic – so what are the best methods for ensuring patient safety and trial integrity during this transition? In this article, we will discuss some of the important aspects to consider when taking a therapeutic trial from the clinic to the patient’s home.
The full FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic is available here.
Cambridge Cognition has announced a significant new contract providing digital health technologies to a major pharmaceutical company for application in a clinical stage development programme.
A negative, perceptual bias is associated with the onset and maintenance of mood disorders, and is therefore a therapeutic avenue of interest. Here we will discuss the launch of an objective assessment of emotional bias as a potential biomarker of mood.
What will happen when we eventually develop a treatment that halts the development of early Alzheimer’s disease? Being first-in-class, pharmacovigilance post-marketing will be vitally important to ascertain the long-term effects of the drug: both positive and negative. We need to be prepared for a breakthrough and pre-emptively identify technologies which can find the right patients likely to benefit from the drug and monitor treatment effects in the real world.
Drug development typically relies upon clinical endpoints established within very controlled laboratory environments. Digital health technologies now provide the opportunity to transition data collection from the clinic into people’s personal lives, thereby providing more accurate conclusions about how a compound can influence their day-to-day life.
High-frequency digital health assessments can not only characterize clinically-relevant data as it occurs in real-time, but capture this information within the patient’s home environment. Therefore, digital health platforms provide an ecologically valid data source which directly maps on to an individual’s daily functioning and real-world outcomes.
Comprehensive neuropsychological testing typically takes hours to complete, which can be mentally and physically burdensome for patients. Furthermore, the travel required and overall time-commitment to undergo these procedures within a clinic can result in decreased study compliance. Together these factors can confound conclusions concerning treatment efficacy. Here we will discuss how digital health can reduce these burdens when implementing therapeutic interventions to improve patient outcomes.
In the first of our digital health series we will outline what the term means, and the opportunities offered, within the context of clinical trials in psychiatry.
The contemporary framework for designing clinical trials is to build a comprehensive cognitive profile of the patient population from thorough but infrequent assessments. However, this framework struggles to capture the daily fluctuations in mood and cognition that many individuals with psychiatric disorders experience. Here we will discuss how the advent of digital health offers the opportunity to capture a more holistic representation of patients’ cognitive function from high-frequency assessments.
NeuroVocalix enables novel voice-based cognitive assessments to be delivered directly to patients through mobile and tele-health platforms, helping to improve outcomes in clinical trials, aid clinical decision-making and play an important role in the management of long-term conditions such as chronic pain.
Digital cognitive biomarkers are typically active or passive: but which approach enhances clinical trial success? Here we will define how active and passive cognitive biomarkers function in clinical trials, to conclude their optimal application.
Biomarkers are important for the detection of disease-relevant information to help recruit, stratify and monitor patients, and to evaluate the safety and efficacy of compounds. Here we’ll discuss what digital biomarkers are and how they offer an opportunity to revolutionize research and drug development in psychiatric and neurological disorders.
Mental wellbeing is integral to the health and functioning of the workforce, the compromise of which can have serious social and financial ramifications - but what actions can employers take to promote mental wellbeing?
Healthy Amplified are using CANTAB® technology to expand their population health platform offering to adults.
Neural Network classification of longitudinal cognitive data for prediction of individual-level chan
For the first time, Neural Network classifiers have been applied to changes in CANTAB PAL performance between baseline and 10 months to accurately predict the development of MCI at 20 months. Dr Elizabeth Baker, Statistical Scientist at Cambridge Cognition, presented the novel findings at AAIC 2018.
We caught up with brain health and workplace mental performance consultant, Dr Jenny Brockis, on how tools like CANTAB BrainHealth can be used to promote mental wellbeing at work.
We are pleased to announce our partnership with Dementias Platform UK (DPUK), the world’s largest study group in dementia research formed to accelerate the development of effective, and ultimately preventative, treatments for diseases such as Alzheimer’s.
We are very pleased to announce a planned new software product to assess mental health and wellbeing at work, CANTAB BrainHealth™.
We’re delighted to announce a new $0.5m contract with a major pharmaceutical company for the use of our Cognition Kit digital health software in a clinical trial.
Exciting new research shows not only that web-based cognitive assessments are suitable for older adults but, for many, computerised assessments are actually preferable to traditional pen-and-paper tasks.
At the 2017 International CNS Summit in Boca Raton, Florida, we were pleased to release the positive results from a pilot study into the evaluation of cognition and mood using wearable technology in patients with MDD.
Cognition Kit and Takeda have collaborated to deliver high frequency assessments of mood and cognition in major depressive disorder, using the Apple Watch.
Cambridge Cognition are attending the Collaborating for Novel Solutions (CNS) Summit: 16th-19th November 2017.
New data demonstrates possibility for speech recognition and online assessments to enhance clinical trials in Alzheimer’s disease.
A new system being developed by Cambridge Cognition with Innovate UK funding will provide a non-invasive, inexpensive means of accurately monitoring levels of pain by combining artificial intelligence technology and cognitive neuroscience.
Showcasing a range of digital neurotechnologies to improve the research, diagnosis and treatment in Alzheimer's disease.
Exploring the use of automated voice based cognitive assessments on consumer voice platforms.
Cambridge Cognition is attending the Alzheimer's Association International Conference in London.
Company CSO honoured at this year's ceremony celebrating leading health-tech innovators.
Dr Jenny Barnett, Chief Scientific Officer for Cambridge Cognition looks at how digital innovations are helping our brain health.