Efficacy of RGn600 for treating mild-to-moderate Alzheimer's Disease
Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)
This study is testing a new device called RGn600 to see if it can help improve memory and quality of life for people with mild-to-moderate Alzheimer's Disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | REGEnLIFE SAS Industry-sponsored |
| Locations | 6 sites (Castres and 5 other locations) |
| Trial ID | NCT05926011 on ClinicalTrials.gov |
What this trial studies
This investigation evaluates the efficacy of the RGn600 device, which combines PhotoBioModulation and Static Magnetic Stimulation, in patients with mild-to-moderate Alzheimer's Disease. The study is multicentric and will enroll 108 patients in France, who will be randomized to receive either the active RGn600 device or a sham device over a 26-week treatment period. Patients will undergo treatment sessions and be assessed for cognitive function, quality of life, and other health metrics at multiple follow-up visits over a year. The aim is to determine if this innovative non-invasive approach can reduce inflammation linked to Alzheimer's Disease.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 55 to 85 diagnosed with mild-to-moderate Alzheimer's Disease.
Not a fit: Patients with severe Alzheimer's Disease or those not meeting the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive function and quality of life for patients with Alzheimer's Disease.
How similar studies have performed: While this approach is innovative, similar studies using photobiomodulation have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Castres and 5 other locations
- CHIC Castres Mazamet Site Autan — Castres, France (Recruiting)
- CH Lavaur — Lavaur, France (Recruiting)
- Hôpital Lariboisière — Paris, France (Not_yet_recruiting)
- Hôpital Broca — Paris, France (Not_yet_recruiting)
- Hôpital de la Timone, — Timone, France (Not_yet_recruiting)
- Toulouse University Hospital Gerontopole — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Julien DELRIEU — Toulouse University Hospital Gerontopole
- Study coordinator: Guillaume CHAMPLEBOUX
- Email: gchampleboux@regenlife.com
- Phone: +33 649 813 454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.