Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorREGEnLIFE SAS
About this trial
This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt). It combines 2 technologies:
* PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs) * Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field.
Considering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RGn600
- RGn600 Sham
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov