REGEnLIFE, a French company specialising in the research and development of innovative neurostimulation technologies for the prevention and treatment of neurodegenerative diseases, has announced the expansion of its pivotal clinical trial for Alzheimer’s disease, Light4Life, with the addition of two new hospital centres in Paris: Lariboisière Hospital and Broca Hospital.
Following the initial launch in partnership with Toulouse University Hospital in September 2023 and the opening of two further centres in the Occitanie region, in Lavaur and Castres, these new sites in Paris will help to speed up the recruitment of patients aged between 55 and 85 with mild to moderate Alzheimer’s disease.
The study, led by the principal investigator, Dr Julien Delrieu, will be joined by new investigators, recognised specialists in Alzheimer’s disease, Professor Claire Paquet and Dr Marie-Laure Seux.
Light4Life, a study offering hope to people with Alzheimer’s disease
108 patients aged between 55 and 85 with mild Alzheimer’s disease are currently being recruited at the two Parisian centers. These participants, who have been randomly assigned to two groups, will receive either the REGEnLIFE treatment or a placebo for six months. They will be monitored regularly for 12 months at the hospital by the investigator and their team through clinical and neuropsychological assessments and regular blood tests. To ensure an objective evaluation, this study will be conducted as a double-blind trial, meaning that neither the medical team nor the patient will know the nature of the device being used.
Dr Julien Delrieu, a geriatric neurologist at Toulouse University Hospital and principal investigator of the Light4Life study, explains: “ “The ongoing pivotal clinical trial represents a major step forward in exploring new therapeutic strategies for Alzheimer’s disease. By targeting both the brain and the gut, this innovative approach could bring about a lasting improvement in the management of the disease. The aim is to assess its effect on the progression of symptoms and patients’ quality of life, with a view to offering a complementary alternative to existing treatments ».
An innovative, non-invasive and promising technology for the treatment of Alzheimer’s disease and other neurodegenerative disorders
REGENLIFE’s PhotoBioModulation medical device, known as the RGn600, uses near-infrared light to simultaneously target the brain and the gut via a headband and an abdominal belt. This innovative treatment is based on recent discoveries concerning the gut-brain axis, which appears to play a key role in neurodegeneration.
A pilot clinical trial conducted between 2018 and 2020 involving around 50 patients aged between 55 and 85 with mild to moderate Alzheimer’s disease demonstrated the safety, ease of use of the treatment and an improvement in certain cognitive functions in patients after just two months of treatment – a very short time compared to drugs currently available on the market or in development.
“The encouraging results of our pilot clinical trial, published in 2022 in the Journal of Alzheimer’s Disease, demonstrated the excellent tolerability of this brain-gut PhotoBioModulation technology in patients with mild to moderate Alzheimer’s disease. These preliminary data suggest an improvement in cognitive function, reinforcing our belief that this innovative approach could offer a promising therapeutic alternative,”, says Professor Jacques Touchon, a neurologist, Chair of the Scientific Advisory Board at REGEnLIFE and co-founder of CTAD.
The future of Alzheimer’s disease treatment will involve a combination of therapeutic techniques, likely including PhotoBioModulation. In 2020, more than 55 million people worldwide were living with dementia, and over 1.2 million people aged 65 and over in France, representing a significant public health challenge.
Strengthening patient involvement to develop new therapeutic approaches
The opening of these two new centres marks a crucial milestone in REGEnLIFE’s development. This expansion will not only speed up patient recruitment for the study, but also enhance the scientific evidence base for photobiomodulation in the treatment of neurodegenerative diseases.
« Speeding up patient recruitment is essential to completing our clinical trial as soon as possible. If the results are positive, this will enable us to validate our technology as a treatment for Alzheimer’s disease. We are proud to be able to rely on the expertise of Professor Paquet and Dr Seux, who will help advance research into new therapeutic approaches for Alzheimer’s disease “says Guillaume Blivet, co-founder and Head of Innovation at REGEnLIFE.”
International recognition from innovation leaders
International recognition from innovation leaders
REGEnLIFE is part of the Alzheimer’s Moonshot, a global programme launched by StartUp Health and supported by Gates Ventures and the Alzheimer’s Drug Discovery Foundation (ADDF), aimed at accelerating innovation in the fight against Alzheimer’s disease. At the same time, this medtech company took part in discussions at the Social Innovation House and the Davos Alzheimer’s Collaborative at the Brain House during the World Economic Forum in Davos, thereby confirming its commitment to cutting-edge research and innovation in the field of neurodegenerative diseases.
Patients interested in the study can contact the participating hospitals for further information on the eligibility criteria.
