Pasquale Fedele, the engineer of digital therapies: “AI and love to fight Alzheimer’s”

55 million people worldwide suffer from dementia. The population is aging and the numbers will double. By 2050, according to the World Health Organization, 139 million cases are expected. There isn’t a cure. There are no drugs. There is no valid test for early diagnosis, which is essential to intervene in time. But there’s good news: artificial intelligence could change that. And on this technology, a startup with an incredible team was born.

Is called MindAhead, headquarters in Berlin, research and development in Siena. Four co-founders. Neuroscientists, engineers, psychologists, entrepreneurs with good exit stories behind them. All with great experience in “digital health”, the new frontier for health care. The CTO is Pasquale Fedele, a computer engineer, computer scientist, specializing in Artificial Intelligence for neuroscience, at his second startup. With the first one he managed to make ALS patients talk through brain waves and he made an exit. The other co-founders are Nina Kiwit (CEO), Manuel Kraus (CPO), Patrick Fissler (CSO).

“We are developing a therapeutic digital solution that contrasts dementia and is based on two pillars: on the one hand it offers a therapeutic program, on the other an AI-based technology for early diagnosis, which aims to intercept the first symptoms. Today there is a technological vacuum. We are able to predict dementia only when it is full-blown, but the first symptoms appear 20 years before the peak of the disease: which is generally between 70 and 80 years of age”. Again: “One study published in the Lancet journal showed that 40% of dementia cases can be slowed and stopped if diagnosed early and lifestyle risk factors corrected.

We are in the field of Digital Therapeutics (DTx): algorithms, artificial intelligence apps, software and technologies which can treat ailments and diseases like drugs. A new frontier of medicine. These are digital solutions, clinically validated that can act together with or as an alternative to drugs. In the USA, the market for digital therapies in 2022 exceeded 2 billion dollars. Europe, with 105 clinical studies, sees Germany and the United Kingdom as the leading countries (source DTx Monitoring Report 2023).

“Europe is pushing for all nations to adopt these new technologies. In Germany, the national health system already reimburses digital health tools. In Italy there is an ongoing discussion. It is estimated that in a year and a half our country will also welcome this treatment modality”. It is no coincidence that MindAhead’s headquarters are in Berlin. Born in 2022, the startup raised 700 thousand euros. I am the pharmaceutical company Roche Pharma and CDP Ventures. They are now working on a 2 million euro round.

Where are you at with the development? “We finished the Minimum viable product (MVP) with the two features. The 8-week therapeutic program is based on Behavioral Activation, a well-established behavioral therapy in psychology that allows you to change wrong behaviors and eliminate the risk factors of dementia related to motor activities, nutrition, socialization. The goal is to certify the therapeutic part as a class 1 medical device by September. For the diagnostic part, we expect to have the certifications by the end of next year. Our solution has an effectiveness that has been validated by years of studies by our co-founder Patrick. With technology, today we improve impact and results.”

From Siena, Pasquale studied, researched and traveled the world driven by the desire to develop technologies that could improve people’s quality of life. She graduated in Computer Engineering at the University of Siena. Master in the study of complex systems. For years he worked as a researcher at the University. Thanks to a European project, he begins to deal with Brain Computer Interface solutions, that neural interface that allows communication between a brain and a computer. Studying the state of the art of these solutions, he wonders: why in 30 years of studies and research we still don’t have concrete applications? “Hence my curiosity was born. I tried to understand how to make those technologies applicable. It was a very articulated and complex path: then the first prototypes arrived, the first validations, the results were positive”.

So Pasquale Fedele founds his first startup: it’s LiquidWeb, he develops innovative technological solutions. He creates Brain Control, a medical device that allows completely paralyzed but cognitively able people, such as ALS patients, to communicating with the outside world through thought: “We have created a software which, using a helmet with wireless electroencephalographic sensors, transforms thoughts into words. I had defined it as a mental joystick: controlled by the thought of imagined movements, it allowed interaction with the computer to compose sentences or control devices robotic”.

Once the prototype was done, I went to try it directly on patients wherever they were. We had some 3 in Italy, 2 in Japan, 1 in Korea. And then I personalized it based on how they reacted: “I remember as if today was the first patient. For 7 years he lived completely paralyzed, with his eyes closed, in a semi-dark room. Doctors and family members didn’t even know if he was still conscious . I went to see him in person. We tried a very first prototype and immediately we noticed positive results. Day after day, the patient began to answer the questions I asked him. One of the first things we asked him was : do you know the name of your nephew? The little one was born five years earlier, when the man was already in a locked-in state. She replied the correct name. She was aware of everything that had happened. We opened his eyelids with our hands, we asked him: do you see? He told us yes. It was an incredible emotion. I still hear the scream of the daughter who witnessed those moments. That patient was the spring that pushed me to move forward. It was not easy to raise capital. There are not many patients in this state, completely paralyzed but conscious. Fortunately, I say. But this makes applied research very difficult.”

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With BrianControl, Fedele wins international awards, receives the honor of Knight of Merit. And, at one point, he makes an exit: “Technology can do a lot to improve the human condition on various fronts. Today, thanks to artificial intelligence, there is an enormous driving force and technological progress will be even faster. We are in a moment of disruptive evolution. We have technologies that could improve the human condition of many people. We need courage and many entrepreneurial initiatives. But, tomorrow I’ll be 50, and if I had to take stock of everything I’ve seen and I’ve learned, even working with patients in extreme conditions, is that there is something stronger than technology. And it is love. It is love, the most disruptive force. That man paralyzed in a bed for 7 years has never been left. Every day his wife and children were around him. They didn’t know if he was there or not. They didn’t have a match. Yet they were there. My technology has allowed a huge thing, but it’s nothing compared to that love that they managed to give him for 7 years. What moves me also in the professional field is the love for the human race and for those close to us. I’ve tried to follow my passions, technology before anything else, I’ve created companies, given jobs and opportunities, but I’ve been very lucky. I have received so much, I have wonderful people around me, I have never been discouraged because those who were next to me supported me. I was open to exchange and new experiences. There are people who have given me so much. And then opportunities arise from people”. Again: “I have four children. The first two, 21 and 19, study engineering. One aerospace, the other computer science. The girl is 16 years old and attends the third scientific high school, the youngest is 11 years old. I take turns taking them with me when I go abroad. Have I infected them? For my children and for the new generations, I dream that they understand the value of love. My wife and I try to lead by example. It is love, the meaning of life. Even at work. It is normal that there are differences. We are a team of 10 people from 5 different countries. We have completely different ways of doing, of speaking, of pigs. Every day we have two choices: to see this diversity as a threat or as an enrichment. Every day we are called to choose between good or evil. Saint Paul said: Love and do what you want. It’s not always easy, because our nature is mischievous and sometimes it doesn’t lead us to choose the good. But if loving is our main commitment, everything else goes smoothly”.

Chapeau. A last question: Will we beat Alzheimer’s? “Yes, for that 40% of the cases I was talking about earlier. And it will be in a few years and not in decades”.