Light and magnets: a new weapon against Alzheimer's?
NCT ID NCT05926011
First seen Aug 10, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This trial tests whether a wearable device called RGn600 can slow cognitive decline in people with mild-to-moderate Alzheimer's disease. The device, worn as a helmet and abdominal belt, delivers red-to-near-infrared light and static magnetic fields, aiming to reduce inflammation along the brain-gut axis. About 108 participants will be randomly assigned to receive the active device or an inactive sham version, with cognitive changes measured over 26 weeks. If successful, this non-invasive approach could offer a new way to manage Alzheimer's symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RGn600, a non-invasive helmet and abdominal belt device combining photobiomodulation (red to near-infrared light) and static magnetic stimulation
- What this could lead to
- If effective, this device could offer a drug-free way to slow cognitive decline in Alzheimer's disease, potentially improving quality of life for patients and families.
- What could go wrong
- This is a pivotal trial, but the device's benefit is unproven. It may not outperform the sham, and effects could be modest or temporary. The mechanism—reducing brain-gut inflammation—is still theoretical.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female aged 55 to 85 years old (both included) * Diagnosed with AD according to McKhann et al. international criteria dated 2011 * With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26 * With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including calcium, creatinine, clearance, alanine aminotransferase, aspartate aminotransferase, bilirubin, coagulation, C-reactive protein) dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator * With brain Computed Tomography (CT) or/and Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator * In case of treatment with AD symptomatic treatments (memantine and acetylcholinesterase inhibitors) and psychotropic treatments (anxiolytics, antidepressants and neuroleptics): with a stable dose of such treatments 4 weeks before inclusion * Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator * Affiliated to French social security * Who provided, with his/her caregiver, a dated and signed informed consent form. Exclusion Criteria: * Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle") * Patient deprived of liberty or hospitalized without consent * Non-menopausal woman * Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before the end of the study * Patient living in a medical facility * Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion * Patient with skin lesions on the treatment application area (abdomen or head) * Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.) * Patient diagnosed with a stroke within 3 months prior inclusion * Patients with ferromagnetic material (i.e., iron, nickel, cobalt or any metal alloy) on or near the head or abdomen, or implanted with a pacemaker * Patient with a risk of epileptic seizure * Patient with a genetic form of AD * Patient with major physical or neurosensorial disorders that may interfere with neurological assessments * Patient with chronic psychosis or psychotic episodes * Patient addicted to alcohol or drugs * Patient with known and non-supplemented vitamin B12 and folic acid deficiencies * Patient with known untreated hypothyroidism * Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion * Patient not able to meet treatment sessions as deemed by the investigator * Patient not able to complete requested investigation assessments as deemed by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biofortis
RECRUITINGSaint-Herblain, 44800, France
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CH Lavaur
RECRUITINGLavaur, 81500, France
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CHIC Castres Mazamet Site Autan
RECRUITINGCastres, 81100, France
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Hôpital Broca
RECRUITINGParis, 75013, France
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Hôpital Lariboisière
RECRUITINGParis, 75010, France
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Hôpital des Charpennes - HCL
RECRUITINGVilleurbanne, 69100, France
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Toulouse University Hospital Gerontopole
RECRUITINGToulouse, 31 000, France
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