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

Alzheimer Disease Clinical Trial

— LIGHT4LIFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926011
• Other study ID #: LIGHT4LIFE
• Secondary ID: 2022-A02556-37
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: REGEnLIFE SAS
• Contact: Guillaume CHAMPLEBOUX
• Phone: +33 649 813 454
• Email: gchampleboux[@]regenlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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 and fecal 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). 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 and fecal samples as well such as Inflammatory blood markers (iAGE) and fecal microbiota and metabolome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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 living in a medical facility
• Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion
• 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
• 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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• RGn600
RGn600 with a 10 Hz-pulsed wave mode light emission
• RGn600 Sham
RGn600 inactivated

Locations

Country	Name	City	State
France	Toulouse University Hospital Gerontopole	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
REGEnLIFE SAS	RCTs, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	[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 Aß42/Aß40 ratio	Day 0, Week 26, Week 52
Other	[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)	Day 0, Week 26, Week 52
Other	[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	Day 0, Week 26, Week 52
Other	[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)	Day 0, Week 26, Week 52
Primary	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	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
Secondary	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)	Day 0, Week 26, Week 52
Secondary	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)	Day 0, Week 26, Week 52
Secondary	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)	Day 0, Week 26, Week 52
Secondary	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)	Day 0, Week 26, Week 52
Secondary	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	Day 0, Week 26, Week 52
Secondary	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)	Day 0, Week 26, Week 52
Secondary	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	Day 0, Week 26, Week 52
Secondary	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	Day 0, Week 26, Week 52
Secondary	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	Day 0, Week 26, Week 52
Secondary	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	Day 0, Week 26, Week 52
Secondary	Incidence of Adverse Events (AEs)	Proportion of subjects with at least one Adverse Event (AE)	Throughout the investigation (from Day 0 to Week 52)
Secondary	Incidence of RGn600's Adverse Device Effects (ADEs)	Proportion of subjects with at least one Adverse Device Effect (ADE)	Throughout the investigation (from Day 0 to Week 52)
Secondary	Incidence of RGn600's Device Deficiencies (DDs)	Proportion of subjects with at least one Device Deficiency (DD)	Throughout the investigation (from Day 0 to Week 52)
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	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)	Day 0, Week 8, Week 26, Week 52
Secondary	Medico-economic interest of RGn600 treatment with regards to healthcare consumption	Resource Utilization in Dementia (RUD) questionnaire filled in by the patient/caregiver.	Day 0, Week 26