An interventional study of RGn600 and RGn600 Sham in Alzheimer Disease, sponsored by REGEnLIFE SAS. Recruiting at 7 sites in France. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by REGEnLIFE SAS · Not applicable, Interventional, and Treatment
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:
Considering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.
This multicentric investigation is planned to include 108 patients in France who will be followed up to 52 weeks.
Patients meeting all eligibility criteria will be randomized on a 1: 1 ratio into one of the two following treatment groups: active RGn600 device or sham device (inactivated RGn600). The site investigation teams and patients/caregivers will be blinded. The device will be applied to the patients during 26 weeks through 20-min onsite sessions following the below pattern:
Follow-up will continue up to W52 ± 2 weeks
At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, date of AD diagnosis, comorbidities, concomitant medications, sociological data. A blood sample for APOE genotyping will be also performed.
Endpoints will be evaluated during 4 onsite visits at Day 0 (Inclusion, randomization to the active or sham group and first treatment session), W8 (last treatment session of), W26 (last treatment session of) and W52 ± 2 weeks. During these visits:
Within the context of this investigation, a biobank will be created based on blood, fecal and saliva samples of patients included by Toulouse University Hospital Gerontopole site:
The biobank will be located at the site. The objective of this biobank will be to perform subsequent analysis on blood samples of AD blood markers. Other analyses might be conducted on blood, fecal and saliva samples as well such as Inflammatory blood markers (iAGE), fecal microbiota and metabolome and salivary micro RiboNucleic Acid (microRNAs)
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 108 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →REGEnLIFE SAS is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RGn600 with a 10 Hz-pulsed wave mode light emission
Device: RGn600
Inactivated RGn600
Device: RGn600 Sham
RGn600 with a 10 Hz-pulsed wave mode light emission
RGn600 inactivated
Evolution of patient's cognition between Day 0 and Week 26 as measured with the AD Assessment Scale-cognitive subscale (ADAS-cog) score
Absolute change (Week 26-Day 0) in ADAS-cog score
Time frame: Day 0, Week 26
Evolution of patient's cognition from Day 0 to Week 8, from Day 0 to Week 52 and from Week 26 to Week 52 as measured with the AD Assessment Scale-cognitive subscale (ADAS-cog) score
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the Mini Mental State Examination (MMSE)
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the Category Naming Test (CNT)
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the scores of the Digit Symbol Substitution Test (DSST)
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the Trail Making Test part A and B (TMT A \& B)
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the Clinical Dementia Rating - Sum of Boxes (CDR-SB) scale
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the AD Composite Score (ADCOMS)
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Evolution of the score of the Digit span test
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's autonomy
Evolution of the Instrumental Activities of Daily Living (IADL) questionnaire score
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's Overall clinical response
Evolution of the Clinical Global Impression (CGI) scale score
Time frame: Day 0, Week 26, Week 52
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's Quality of life
Evolution of the EuroQoL 5 Dimensions-5 Levels (EQ-5D-5L) score
Time frame: Day 0, Week 26, Week 52
Incidence of Adverse Events (AEs)
Proportion of subjects with at least one Adverse Event (AE)
Time frame: Throughout the investigation (from Day 0 to Week 52)
Incidence of RGn600's Adverse Device Effects (ADEs)
Proportion of subjects with at least one Adverse Device Effect (ADE)
Time frame: Throughout the investigation (from Day 0 to Week 52)
Incidence of RGn600's Device Deficiencies (DDs)
Proportion of subjects with at least one Device Deficiency (DD)
Time frame: Throughout the investigation (from Day 0 to Week 52)
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of Complete blood count, including platelets
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of electrolytes, including calcium
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of Creatinine
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of creatinine clearance
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of urea
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of ASpartate AminoTransferase (ASAT)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of ALanine AminoTransferase (ALAT)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of Gamma-GT
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of ALkalyne Phosphatase (ALP)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of level of safety blood markers
Change from baseline (Day 0) of level of bilirubin
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Blood pressure
Measure of Blood pressure (mmHg)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Weight
Measure of Weight (Kg)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Heart rate
Measure of Heart rate (beats/min)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Temperature
Measure of Temperature (°C)
Time frame: Day 0, Week 8, Week 26, Week 52
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of ElectroCardioGram (ECG) interpretation
ElectroCardioGram (ECG) interpretation (Normal / Abnormal - Abnormality description)
Time frame: Day 0, Week 8, Week 26, Week 52
Medico-economic interest of RGn600 treatment with regards to healthcare consumption
Resource Utilization in Dementia (RUD) questionnaire filled in by the patient/caregiver.
Time frame: Day 0, Week 26
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Evolution of Aβ42/Aβ40 ratio
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Evolution of level of Glial Fibrillary Acidic Protein (GFAP)
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Evolution of level of NeuroFilament Light (NFL) protein
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Evolution of level of Phosphorylated tau 217 (p-tau 217)
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's microbiota
Evolution of microbiota
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's metabolome
Evolution of metabolome
Time frame: Day 0, Week 26, Week 52
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD saliva markers
Evolution of microRNAs
Time frame: Day 0, Week 26, Week 52
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jun 2027, 47 months after the start.
Of 77 industry-sponsored interventional studies with no phase under Alzheimer Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 47 months is above that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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REGEnLIFE SAS