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Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease (LIGHT4LIFE)

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RGn600
RGn600 Sham
Sponsored by
REGEnLIFE SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toulouse University Hospital GerontopoleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active RGn600

Sham

Arm Description

RGn600 with a 10 Hz-pulsed wave mode light emission

Inactivated RGn600

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
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)
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)
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)
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
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)
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
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
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
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
Incidence of Adverse Events (AEs)
Proportion of subjects with at least one Adverse Event (AE)
Incidence of RGn600's Adverse Device Effects (ADEs)
Proportion of subjects with at least one Adverse Device Effect (ADE)
Incidence of RGn600's Device Deficiencies (DDs)
Proportion of subjects with at least one Device Deficiency (DD)
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
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
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
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
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
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)
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)
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
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)
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
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)
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)
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)
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)
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)
Medico-economic interest of RGn600 treatment with regards to healthcare consumption
Resource Utilization in Dementia (RUD) questionnaire filled in by the patient/caregiver.

Full Information

First Posted
June 6, 2023
Last Updated
August 16, 2023
Sponsor
REGEnLIFE SAS
Collaborators
RCTs, University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05926011
Brief Title
Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
REGEnLIFE SAS
Collaborators
RCTs, University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An interventional, prospective, multicentric, randomized, comparative and double-blinded pivotal clinical investigation
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active RGn600
Arm Type
Experimental
Arm Description
RGn600 with a 10 Hz-pulsed wave mode light emission
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Inactivated RGn600
Intervention Type
Device
Intervention Name(s)
RGn600
Intervention Description
RGn600 with a 10 Hz-pulsed wave mode light emission
Intervention Type
Device
Intervention Name(s)
RGn600 Sham
Intervention Description
RGn600 inactivated
Primary Outcome Measure Information:
Title
Evolution of patient's cognition between Day 0 and Week 26 as measured with the AD Assessment Scale-cognitive subscale (ADAS-cog) score
Description
Absolute change (Week 26-Day 0) in ADAS-cog score
Time Frame
Day 0, Week 26
Secondary Outcome Measure Information:
Title
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
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the Mini Mental State Examination (MMSE)
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the Category Naming Test (CNT)
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the scores of the Digit Symbol Substitution Test (DSST)
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the Trail Making Test part A and B (TMT A & B)
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the Clinical Dementia Rating - Sum of Boxes (CDR-SB) scale
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the AD Composite Score (ADCOMS)
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's cognitive functions
Description
Evolution of the score of the Digit span test
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's autonomy
Description
Evolution of the Instrumental Activities of Daily Living (IADL) questionnaire score
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's Overall clinical response
Description
Evolution of the Clinical Global Impression (CGI) scale score
Time Frame
Day 0, Week 26, Week 52
Title
Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's Quality of life
Description
Evolution of the EuroQoL 5 Dimensions-5 Levels (EQ-5D-5L) score
Time Frame
Day 0, Week 26, Week 52
Title
Incidence of Adverse Events (AEs)
Description
Proportion of subjects with at least one Adverse Event (AE)
Time Frame
Throughout the investigation (from Day 0 to Week 52)
Title
Incidence of RGn600's Adverse Device Effects (ADEs)
Description
Proportion of subjects with at least one Adverse Device Effect (ADE)
Time Frame
Throughout the investigation (from Day 0 to Week 52)
Title
Incidence of RGn600's Device Deficiencies (DDs)
Description
Proportion of subjects with at least one Device Deficiency (DD)
Time Frame
Throughout the investigation (from Day 0 to Week 52)
Title
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
Description
Change from baseline (Day 0) of level of Complete blood count, including platelets
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of electrolytes, including calcium
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of Creatinine
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of creatinine clearance
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of urea
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of ASpartate AminoTransferase (ASAT)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of ALanine AminoTransferase (ALAT)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of Gamma-GT
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of ALkalyne Phosphatase (ALP)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
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
Description
Change from baseline (Day 0) of level of bilirubin
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Blood pressure
Description
Measure of Blood pressure (mmHg)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Weight
Description
Measure of Weight (Kg)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Heart rate
Description
Measure of Heart rate (beats/min)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of Temperature
Description
Measure of Temperature (°C)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Evolution from Day 0 to Week 8, Day 0 to Week 26 and from Day 0 to Week 52 of ElectroCardioGram (ECG) interpretation
Description
ElectroCardioGram (ECG) interpretation (Normal / Abnormal - Abnormality description)
Time Frame
Day 0, Week 8, Week 26, Week 52
Title
Medico-economic interest of RGn600 treatment with regards to healthcare consumption
Description
Resource Utilization in Dementia (RUD) questionnaire filled in by the patient/caregiver.
Time Frame
Day 0, Week 26
Other Pre-specified Outcome Measures:
Title
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Description
Evolution of Aβ42/Aβ40 ratio
Time Frame
Day 0, Week 26, Week 52
Title
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Description
Evolution of level of Glial Fibrillary Acidic Protein (GFAP)
Time Frame
Day 0, Week 26, Week 52
Title
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Description
Evolution of level of NeuroFilament Light (NFL) protein
Time Frame
Day 0, Week 26, Week 52
Title
[Exploratory endpoint from biobanking] Evolution from Day 0 to Week 26 and from Day 0 to Week 52 of patient's AD blood markers
Description
Evolution of level of Phosphorylated tau 217 (p-tau 217)
Time Frame
Day 0, Week 26, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume CHAMPLEBOUX
Phone
+33 649 813 454
Email
gchampleboux@regenlife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume BLIVET
Organizational Affiliation
REGEnLIFE SAS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacques TOUCHON
Organizational Affiliation
Montpellier University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julien DELRIEU
Organizational Affiliation
Toulouse University Hospital Gerontopole
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital Gerontopole
City
Toulouse
ZIP/Postal Code
31 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien DELRIEU, Neurologist-Geriatrician
Phone
+33 5 61 77 70 58
Email
delrieu.j@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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