Actively Recruiting
Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
Led by REGEnLIFE SAS · Updated on 2025-04-06
108
Participants Needed
6
Research Sites
175 weeks
Total Duration
On this page
Sponsors
R
REGEnLIFE SAS
Lead Sponsor
R
RCTs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 55 to 85 years old (both included)
- Diagnosed with Alzheimer's disease according to McKhann et al. international criteria dated 2011
- Mild-to-moderate Alzheimer's disease with MMSE score between 10 and 26
- Blood test results for specific markers dated less than 1 year ago as deemed by the investigator
- Brain CT or MRI scan dated less than 1 year ago as deemed by the investigator
- Stable dose of Alzheimer's symptomatic or psychotropic treatments for at least 4 weeks before inclusion if applicable
- Has a caregiver who is sufficiently and regularly present and can help throughout the investigation
- Affiliated to French social security
- Provided signed informed consent with caregiver
You will not qualify if you...
- Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")
- Patient deprived of liberty or hospitalized without consent
- Non-menopausal woman
- Taking disease-modifying treatments like Leqembi or any other authorized before study end
- Living in a medical facility
- Surgery on abdomen or head within 3 months prior to inclusion
- Skin lesions on abdomen or head treatment areas
- Short-term life-threatening conditions such as evolving cancer, non-stable heart failure, or severe organ failure
- Stroke within 3 months prior to inclusion
- Presence of ferromagnetic material near head or abdomen or implanted pacemaker
- Risk of epileptic seizure
- Genetic form of Alzheimer's disease
- Major physical or neurosensorial disorders affecting neurological assessments
- Chronic psychosis or psychotic episodes
- Alcohol or drug addiction
- Known untreated vitamin B12 or folic acid deficiencies
- Known untreated hypothyroidism
- Participation in another investigational study with medical device or drug within 30 days prior
- Unable to meet treatment sessions as judged by investigator
- Unable to complete required assessments as judged by investigator
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHIC Castres Mazamet Site Autan
Castres, France, 81100
Actively Recruiting
2
CH Lavaur
Lavaur, France, 81500
Actively Recruiting
3
Hôpital Lariboisière
Paris, France, 75010
Not Yet Recruiting
4
Hôpital Broca
Paris, France, 75013
Not Yet Recruiting
5
Hôpital de la Timone,
Timone, France, 13005
Not Yet Recruiting
6
Toulouse University Hospital Gerontopole
Toulouse, France, 31 000
Actively Recruiting
Research Team
G
Guillaume CHAMPLEBOUX
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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