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

NCT05926011 | Recruiting DMC

• 2 other identifiers: LIGHT4LIFE2022-A02556-37
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 6

Brief 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). 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer; Neurostimulation; Optics and photonics; Photobiomodulation; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Medical Device

Outcome Measures

Primary Outcomes (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

  Day 0, Week 26

Secondary Outcomes (30)

• 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

  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

  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

  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

  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

  Day 0, Week 26, Week 52

Other Outcomes (7)

• [Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers

  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

  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

  Day 0, Week 26, Week 52

Study Arms (2)

Active RGn600

EXPERIMENTAL

RGn600 with a 10 Hz-pulsed wave mode light emission

Device: RGn600

Sham

SHAM COMPARATOR

Inactivated RGn600

Device: RGn600 Sham

Interventions

RGn600 DEVICE

RGn600 with a 10 Hz-pulsed wave mode light emission

Active RGn600

RGn600 Sham DEVICE

RGn600 inactivated

Sham

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 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.)
• 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

Sponsors & Collaborators

• REGEnLIFE SAS: lead
• RCTs: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (6)

CHIC Castres Mazamet Site Autan

Castres, 81100, France

RECRUITING

CH Lavaur

Lavaur, 81500, France

RECRUITING

Hôpital Lariboisière

Paris, 75010, France

NOT YET RECRUITING

Hôpital Broca

Paris, 75013, France

NOT YET RECRUITING

Hôpital de la Timone,

Timone, 13005, France

NOT YET RECRUITING

Toulouse University Hospital Gerontopole

Toulouse, 31 000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Guillaume BLIVET

  REGEnLIFE SAS

  STUDY DIRECTOR

• Jacques TOUCHON

  Montpellier University

  STUDY CHAIR

• Julien DELRIEU

  Toulouse University Hospital Gerontopole

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume CHAMPLEBOUX

CONTACT

+33 649 813 454; gchampleboux@regenlife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An interventional, prospective, multicentric, randomized, comparative and double-blinded pivotal clinical investigation

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 3, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)