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Alzheimer DiseaseLIGHT4LIFENCT05926011

Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease

A study testing RGn600 in people with Alzheimer Disease, run by REGEnLIFE SAS at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
RGn600
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
7 sitesFrance
Study dates
24 Jul 2023to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Guillaume CHAMPLEBOUX contact

+33 649 813 454

gchampleboux@regenlife.com

7 sites in 1 country

France7 sites, 7 recruiting

  • CHIC Castres Mazamet Site Autan

    Castres, 81100

    Marie-Noëlle Cufi, Geriatrician, marie-noelle.cufi@chic-cm.fr

    Recruiting

  • CH Lavaur

    Lavaur, 81500

    Louise Naccache, Geriatrician, l.naccache@ch-lavaur.fr

    Recruiting

  • Hôpital Lariboisière

    Paris, 75010

    Claire PAQUET, Neurologist, claire.paquet@aphp.fr

    Recruiting

  • Hôpital Broca

    Paris, 75013

    Marie Laure SEUX, Geriatrician, marie-laure.seux@aphp.fr

    Recruiting

  • Biofortis

    Saint-Herblain, 44800

    Maud JOURDAIN, General practitioner, maud.jourdain@biofortis.fr

    Recruiting

  • Toulouse University Hospital Gerontopole

    Toulouse, 31 000

    Julien DELRIEU, Neurologist-Geriatrician, +33 5 61 77 70 58, delrieu.j@chu-toulouse.fr

    Recruiting

  • Hôpital des Charpennes - HCL

    Villeurbanne, 69100

    Antoine GARNIER-CRUSSARD, Geriatrician, antoine.garnier-crussard@chu-lyon.fr

    Recruiting

Other trials in France

About this study

Official title: Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)

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.

Read the detailed description

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:

  • 5 treatment sessions per week from Week 1 (W1) to W8
  • 3 treatment sessions per week from W9 to W16
  • 2 treatment sessions per week from W17 to W26 Throughout the investigation, patients will be treated per randomization with the device initially allocated by the IWRS.

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:

  • Patient's cognition and autonomy will be assessed through neurological scales and/or neuropsychological tests
  • Patient's quality of life and medico-economic interest of RGn600 treatment with regards to healthcare consumption will be assessed through questionnaires fulfilled by the patient himself/herself with the help of his/her caregiver
  • The safety of RGn600 will be assessed : collection of all AEs and device deficiencies, blood samples for safety analysis, clinical exams

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:

  • Blood samples will be collected for all patients included by this site (at D0, W26 and W52)
  • Fecal samples will be collected for the first 30 consecutive patients included by this site (at D0, W26 and W52).
  • Saliva samples will be collected for the patients included by this site after the substantial modification approval (at D0, W26 and W52).

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)

Being tested
RGn600, RGn600 Sham
Keywords
Alzheimer, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device
Medical subject headings
Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGn600Device

    RGn600 with a 10 Hz-pulsed wave mode light emission

  • RGn600 ShamDevice

    RGn600 inactivated

Study groups in NCT05926011
Study groupRoleWhat they receive
Active RGn600ExperimentalRGn600 with a 10 Hz-pulsed wave mode light emission
Receives: Device: RGn600
ShamSham comparatorInactivated RGn600
Receives: Device: RGn600 Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 0, Week 26

Secondary outcomes (30)

  1. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  2. 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)

    Measured: Day 0, Week 26, Week 52

  3. 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)

    Measured: Day 0, Week 26, Week 52

  4. 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)

    Measured: Day 0, Week 26, Week 52

  5. 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)

    Measured: Day 0, Week 26, Week 52

  6. 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

    Measured: Day 0, Week 26, Week 52

  7. 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)

    Measured: Day 0, Week 26, Week 52

  8. 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

    Measured: Day 0, Week 26, Week 52

  9. 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

    Measured: Day 0, Week 26, Week 52

  10. 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

    Measured: Day 0, Week 26, Week 52

  11. 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

    Measured: Day 0, Week 26, Week 52

  12. Incidence of Adverse Events (AEs)

    Proportion of subjects with at least one Adverse Event (AE)

    Measured: Throughout the investigation (from Day 0 to Week 52)

  13. Incidence of RGn600's Adverse Device Effects (ADEs)

    Proportion of subjects with at least one Adverse Device Effect (ADE)

    Measured: Throughout the investigation (from Day 0 to Week 52)

  14. Incidence of RGn600's Device Deficiencies (DDs)

    Proportion of subjects with at least one Device Deficiency (DD)

    Measured: Throughout the investigation (from Day 0 to Week 52)

  15. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  16. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  17. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  18. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  19. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  20. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  21. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  22. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  23. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  24. 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

    Measured: Day 0, Week 8, Week 26, Week 52

  25. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  26. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  27. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  28. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  29. 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)

    Measured: Day 0, Week 8, Week 26, Week 52

  30. Medico-economic interest of RGn600 treatment with regards to healthcare consumption

    Resource Utilization in Dementia (RUD) questionnaire filled in by the patient/caregiver.

    Measured: Day 0, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start24 Jul 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
An interventional, prospective, multicentric, randomized, comparative and double-blinded pivotal clinical investigation
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05926011
Sponsor's protocol ID
LIGHT4LIFE
Other IDs
2022-A02556-37
Acronym
LIGHT4LIFE
Status last verified
Aug 2026
First submitted
6 Jun 2023
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RGn600 in people with Alzheimer Disease, run by REGEnLIFE SAS at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guillaume CHAMPLEBOUX (+33 649 813 454, gchampleboux@regenlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of patient's cognition between Day 0 and Week 26 as measured with the AD Assessment Scale-cognitive subscale (ADAS-cog) score (time frame: Day 0, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05926011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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