Paris, 17 March 2026 – REGEnLIFE has reached another key milestone in the clinical development of its technology for Alzheimer’s disease. The French company, which specialises in the research and development of innovative photobiomodulation and neuromodulation technologies for the prevention and treatment of neurodegenerative diseases, is opening a new clinical trial centre at the Hospices Civils de Lyon – CHU de Lyon, Hôpital des Charpennes.
This new site marks a further step towards accelerating the recruitment of the study’s 108 patients, aged between 55 and 85 and suffering from mild to moderate Alzheimer’s disease. The study, led nationally by the principal investigator, Dr Julien Delrieu, now benefits from the local expertise of Dr Antoine Garnier-Crussard, a geriatrician at the CMRR at Lyon University Hospital.
Light4Life, a study offering hope for transforming the management of the disease.
Initially launched in September 2023 in partnership with Toulouse University Hospital, the Light4Life pivotal clinical trial rapidly expanded its national network with the opening of four additional centres: Lavaur, Castres, and the Lariboisière and Broca hospitals (AP-HP) in Paris in June 2025.
This momentum continues with the launch of a new recruitment site at Lyon University Hospital (Hôpital des Charpennes). This centre aims to enrol 10 of the 108 patients targeted by the protocol at national level. To date, thanks to the efforts of the first five French research centres, 65 patients have already joined the study.
The rigorous and standardised research protocol is based on the following criteria:
● Patients aged between 55 and 85 with mild to moderate Alzheimer’s disease.
● To ensure the results are completely objective, neither the patients nor the medical teams know whether the device used is active or a placebo.
● Volunteers are randomly assigned to two groups for a 6-month treatment period. During this phase, they undergo 2 to 5 weekly neuromodulation sessions.
● Medical support is provided over a 12-month period and includes neuropsychological assessments, clinical examinations and regular blood tests to accurately monitor changes in cognitive function.
Strengthening patient involment to edvelop new therapeutic approaches
The opening of this new clinical research centre at Lyon University Hospital marks a crucial milestone in REGEnLIFE’s national expansion. To lead this key phase, the start-up is drawing on the local expertise of RCTs, a clinical research organisation (CRO) based in Lyon and headed by Frédéric Mistretta.
“As an organisation specialising in the conduct of clinical trials, RCTs is proud to be contributing to the launch of this new centre at the Hospices Civils de Lyon, which will help to accelerate the development of innovative treatments for Alzheimer’s disease.” “This programme offers promising prospects for improving patient care “This programme offers promising prospects for improving patient care and generating the clinical data needed to evaluate this technology,” says Frédéric Mistretta, President of RCTs in Lyon.
This collaboration not only optimises the operational monitoring of the Light4Life study, but also speeds up the collection of the scientific data required to validate photobiomodulation as a treatment for neurodegenerative diseases.
“The acceleration of patient recruitment, supported by our partner RCTs’ presence in Lyon, is essential to completing our clinical trial as quickly as possible. “We are proud to reach this milestone alongside recognised experts; it is a decisive step towards transforming our technology into a tangible and accessible treatment to address the public health challenges posed by Alzheimer’s disease,” said Guillaume Blivet, co-founder and Director of Innovation at REGEnLIFE.
Photobiomodulation: a non-invasive approach with promising clinical results
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 treatment’s safety and ease of use, as well as improvements in certain cognitive functions in patients after
just two months of treatment¹, which is a very short time compared to drugs currently available on the market or in development.
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 dementia² and more than 1.2 million people aged 65 and over in France³, representing a significant public health challenge.
“The initial results of our pilot trial have demonstrated excellent tolerability and encouraging signs of cognitive improvement after just two months of treatment. This bimodal technology, which acts on the brain-gut axis, represents a major breakthrough. “With the Light4Life study, our aim is to validate a non-invasive and complementary solution to address the public health emergency posed by Alzheimer’s disease,” , says Professor Touchon, a neurologist, Chair of the Scientific Advisory Board at REGEnLIFE and co-founder of CTAD.
¹ Blivet et al., A randomized, double-blind, and sham-controlled trial of an innovative brain-gut PhotoBioModulation therapy: safety and patient compliance. J Alzheimer’s Dis. 2022, 90: 2. doi: 10.3233/JAD-220467
² Alzheimer Disease International https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/
³ Santé Publique France – 2019.
