Alzheimer's disease – a challenge for modern medicine
Alzheimer's disease is one of the greatest challenges of modern medicine. The number of patients worldwide is growing at a dramatic pace – it could exceed 50 million people in the next few decades, burdening not only healthcare systems but also patients' families.
Research on the neural mechanisms underlying cognitive processes, conducted for years at the Department of Neurobiology, allowed us to start cooperation with Cogniquard and carry out research on non-invasive vagus nerve stimulation (VNS). This research laid the foundation for the development of new technological solutions used in the device, which take advantage of the physiological period of memory consolidation – sleep.
Synergy of science and business
The device was presented at the Faculty of Biology and Environmental Protection of the University of Lodz.
– The place of today's meeting is not accidental. It was here, in the laboratories of the Department of Neurobiology, which for many years has focused on the study of the neural mechanisms underlying cognitive processes, that research on non-invasive stimulation of the vagus nerve began 10 years ago, in close cooperation with Cogniquard. The scientific research results proved to be the key to implementation success in the form of the development of a ready-to-use Vguard medical device, which gives hope to millions of patients suffering from Alzheimer's disease. This success shows how valuable the cooperation between research units such as our faculty and technological partners such as Cogniguard is. The synergy of the research potential of universities with the implementation capabilities of companies leads to innovative solutions that successfully serve society
– says Prof. dr hab. Agnieszka Marczak, Dean of the Faculty of Biology and Environmental Protection, University of Lodz.
The Mayor of Lodz, Hanna Zdanowska, who was present at the presentation, spoke about the potential of the project:
– Lodz has been proving for years that it is a city of courage, creativity and groundbreaking ideas. Today, we are meeting to talk about an innovation that can truly change the lives of millions of people around the world – and which was created right here, in our city. Lodz Startup and the team of dr hab. n. med. Adam Broncel have created a solution that could open a new chapter in the treatment of Alzheimer's disease. Technology from Lodz, working in home conditions, gives hope to people who often feel helpless in the face of this disease. This is a huge step forward – for both patients and their families. And a huge reason for pride for our city. Lodz is becoming a place where modern medicine meets technology, business and the courage to think. Such projects show that our city has world-class scientific and innovative potential. That we can create solutions that reach European and American markets, obtain patents, and – most importantly – change people's lives. Alzheimer's disease is one of the greatest challenges of modern times. Therefore, any technology that offers even a modicum of hope is invaluable. And if it is being built here – in Lodz – it is also a confirmation of the direction we are heading as a modern, empathetic and future-oriented city.
Preclinical studies
The event was an excellent opportunity to raise several important issues related to basic research, which was a huge success.
– The task of the team at the Department of Neurobiology was to develop preclinical studies on an animal model that would enable the development of future clinical protocols, parameters of vagus nerve stimulation and the collection of other information necessary in the therapeutic process. Preclinical studies have resulted in numerous publications and conference communications. During this time, we made a significant discovery that dominated subsequent projects. Electrical stimulation of the vagus nerve has been found to induce hippocampal theta rhythm, an EEG activity that is associated with REM sleep and memory consolidation. I would also like to share a personal reflection. There is no greater satisfaction for a researcher who, after years of research, sees how the obtained results acquire application value and form the basis for the implementation of an innovative clinical method that has a significant social dimension, in this case stopping the development of dementia processes. In this respect, this is the greatest reward that has ever come to me
– said Prof. Jan Konopacki, consultant and a researcher under whose supervision the research was conducted, during the conference.
Dr hab. Renata Bocian, Vice-Dean for Education at the Faculty of Biology and Environmental Protection of the University of Lodz, who conducted the research, also explains what it involved:
– Dr hab. n. med. Adam Broncel presented us with the idea of research aimed at checking whether the method of vagus nerve stimulation, used for many years in the treatment of drug-resistant epilepsy, depression and migraine, could be used in the treatment of memory disorders. The demonstration that stimulation of the vagus nerve induces a response in the hippocampus, a brain structure associated with memory and learning processes was a breakthrough in our research. In response to the stimulation, we observed theta rhythm in the hippocampus, which is a physiological marker of memory consolidation. In the next stages, we went a step further, trying to determine the neurochemical basis of the observed effect. The obtained results suggest that vagus nerve stimulation induces increased release of endogenous acetylcholine and noradrenaline in brain structures involved in the memory consolidation process. Activating this mechanism only requires the appropriate initiating stimulus, e.g. an electrical impulse generated by the Vguard device. The data obtained during the study also allowed for the determination of preliminary parameters of optimal stimulation, as it was shown that the effectiveness of this method depends on the use of an appropriate stimulation protocol. As someone who has been conducting scientific research for nearly 30 years, I would like to emphasise that one of the most important aspects of experimental work is the moment when research results become the basis for creating innovative solutions or technologies with real social significance. Research carried out in recent years at the Department of Neurobiology of the University of Lodz well reflects this approach. The results of the performed work, including preclinical studies, have become the foundation for the development of a new therapy for the treatment of cognitive disorders. Participating in a project that resulted in the development of an extremely promising therapeutic method for treating memory disorders based on neuromodulation is a particularly valuable professional experience for me.
Innovation in neurostimulation
The Vguard device is a non-invasive brain stimulator designed for independent use at home during sleep. The device works by sending precisely controlled electrical impulses to the central nervous system via the vagus nerve, affecting the activity of the hippocampus, a key structure for memory consolidation.
– The device takes the form of a textile headband. The therapy involves the use of special electrodes in the form of flexible ear clips. Their shape allows for precise placement around the ear canal, exactly where a branch of the vagus nerve is close to the skin surface. The electrodes are connected to a microstimulator that sends precisely controlled impulses. Stimulation occurs mainly during the REM sleep phase, which supports the natural brain processes associated with consolidating recent memory. The entire process is managed by a mobile application that not only guides the user through the therapy, but also records its progress and enables remote medical supervision
– explains dr hab. n. med. Adam Broncel, the project medical manager and Operational Director at Cogniguard Polska.
Ensuring comfort and safety was crucial for long-term chronic therapy. This required the development of specific stimulation protocols. The developed algorithms dose impulses in accordance with the sleep rhythm and operate below the patient's sensory threshold and below the patient's awakening threshold. Thanks to this, the stimulation is imperceptible, does not disturb sleep and is very well tolerated, as proven by preliminary clinical studies. The therapy can be repeated throughout the night
– adds Adam Broncel.
Real effects
The first studies, lasting 3 to 6 months, were conducted on a group of over 50 patients with early stages of Alzheimer's disease and a mild cognitive impairment (MCI). The results obtained exceeded the research team's expectations. Initially, the goal was only to slow down or stop the progression of the disease. Meanwhile, patients experienced significant, statistically confirmed improvements in cognitive parameters. We saw real benefits in patients: from better orientation and improved concentration to the ability to return to daily activities that were previously difficult. Both patients and their caregivers reported improved quality of life
– says Adam Broncel.
The study was repeated on a smaller group of patients at a centre in Tel Aviv. People in advanced stages of the disease took part in it. The results were similar, although statistically slightly worse, which confirms the general principle of treating neurodegenerative diseases: the earlier the therapy is applied, the greater the probability of achieving a better effect.
The next step
Vguard's innovation is secured by five global patents. The device was the first in the world to obtain the CE MDR medical mark for this indication, allowing it to be used on the European market in the treatment of cognitive disorders in the course of Alzheimer's disease. Preparations are currently underway for extensive, multi-centre clinical trials in Europe and Poland, aimed at further development of the presented therapy. The Vguard device opens up a promising new therapy path for millions of patients worldwide.
Edit: Kamila Knol-Michałowska (Promotion Centre, Faculty of Biology and Environmental Protection, University of Lodz)
Photos: Mateusz Kowalski (Promotion Centre, Faculty of Biology and Environmental Protection, University of Lodz)
