Alzheimer DiseaseNCT03672474
REGEnLIFE RGn530 - Feasibility Pilot
A study testing Photobiomodulation REGEnLIFE RGn530 device in people with Alzheimer Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
REGEnLIFE RGn530 is a photobiomodulation medical device, consisting in a modular helmet and abdominal panel, composed of near-infrared low-level lasers (LLLT), near-infrared and red LEDs as well as a static magnetic field. 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?
- Photobiomodulation REGEnLIFE RGn530 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2018to 13 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 and/or Female ;
- Age between 55-85 years old ;
- Diagnostic of AD according to international criteria of McKhann et al., 2011 [1] ;
- Mild-to-moderate Alzheimer's disease stage with MMSE score between 16 and 26 ;
- Symptomatic treatments specific to AD (Memantine, acetylcholinesterase inhibitors) and pyshotropic treatments (anxiolytics, anti-depressants, neuroleptics) are allowed but must be maintained at fixed doses during the 4 weeks previous to inclusion and during all the study length ;
- Patient approval for biological, eletrophysiological and imaging tests ;
Show all 10Show fewer
- Enough availability to participate daily to the proposed treatment sessions ;
- Given informed, free consent, written and signed by participant and investigator (at the latest on the day of inclusion and before any examination needed for the research) ;
- Affiliated to social security regime or beneficiary of such a regime ;
- Patient given approval to perform a second lumbar puncture (without contraindication) if tests results and/or neurological follow-up need a CSF test for biomarkers ;
Who cannot join
- Clinical and paraclinical details insufficient for AD diagnostic ;
- Genetic form of AD (genetic mutation characterized) ;
- No caregiver to complete neuropsychological scales and evaluation forms ;
- Patient living in a medical institution ;
- Illiteracy or inability to perform psycho-behavioral tests ;
- Physical or neurosensory problems susceptible to interfere with tests
Show all 16Show fewer
- Contraindication or refusal to perform MRI imagerie examinations, PET-FDG, P300 and/or actimetry tests ;
- Patient carrying a pacemaker device or a ferromagnetic compound ;
- Short-term life-threatening pathologies (evolutive cancer, unstable cardiac failure, liver or kidney failure, severe respiratory insufficiency) ;
- Chronic psychosis or psychotic episodes ;
- Alcohol or drug addiction ;
- Epilpesy or other non-neurodegenerative diseases of the central nervous system ;
- Deficits in B12 and non-supplemented folic acid levels ;
- Untreated hypothyroidism ;
- Major skin lesions on treatment application regions (possibility to apply a bandage during the treatment if minor lesions) ;
- Recent major chirurgical intervention at the abdomen in the past three month before inclusion ;
Trial locations and contacts
1 site in 1 country.
France1 site
Montpellier University Hospital, Gui de Chauliac
Montpellier, 34295
About this study
Official title: Pilot Study Evaluating the Safety and Efficacy of a Photobiomodulation Prototype, REGEnLIFE RGn530 Device, on Cognitive Performances Evolution From Mild-to-moderate Alzheimer's Disease Patients
REGEnLIFE RGn530 is a photobiomodulation medical device, consisting in a modular helmet and abdominal panel, composed of near-infrared low-level lasers (LLLT), near-infrared and red LEDs as well as a static magnetic field. RGn device application on both head and abdomen have demonstrated striking efficacy in preclinical studies. The investigator's results clearly indicated that RGn treatment produces a normalization of all parameters that are strongly modified in the model, including memory performances associated to oxidative stress, neuroinflammation or apoptosis markers, microbiota composition and specific markers related to the amyloid or tau processes (Blivet et al., Alzheimers Dement (NY), 2018).
Following such promising results, this pilot clinical study will evaluate the safety and efficacy of REGEnLIFE RGn530 device on cognitive performances evolution from mild-to-moderate Alzheimer's disease patients. The double-blind, randomized, monocentric sham-controlled clinical trial will be performed at the CHU de Montpellier. 64 patients will be enrolled: 32 in photobiomodulation group and 32 in sham group. Each patient will follow 8 weeks of treatment with 5 sessions of 25min per week (total of 40 sessions) and will undergo, for a total period of three months, series of clinical examinations including cognitive evaluation, biological and electrophysiological analyses, sleep recordings, and imaging assessments.
REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective. In the light of anti-amyloid therapeutic approaches lack of success, RGn530 dual treatment is hoped to be particularly valuable as an innovative and extensive treatment strategy for AD.
Read the detailed description
Design : Prospective monocentric double-blind pilot study with 2 parallel groups of 32 patients. One with photobiomodulation (device set up and activated), the other with placebo-sham procedure (device set up but not activated). The study will consist of an inclusion visit (V0, D-30 to D-10), a photobiomodulation start visit (V1, D0), followed by 3 follow-up visits (V2 to D30, V3 to D60 and V4 to D90).
Dispositive : Photobiomodulation device developed by REGEnLIFE, RGn530 consisting of a modular helmet and an abdominal modular panel each comprising modules composed of low intensity infrared lasers (LLLT - Low Level Laser Therapy), infrared and red LEDs and a static magnetic field. The helmet and abdominal panel devices are connected to a steering console. Activation of the device will be done by personnel trained for this purpose by REGEnLIFE.
Originality and innovation : This study proposes to evaluate a new medical photobiomodulation device in the field of neurodegenerative diseases. These techniques have shown positive and promising results in the following areas: wound healing, pain management, inflammation, tissue regeneration, and the following disciplines: neuropsychiatry, dermatology and neurology.
Photobiomodulation is a technology of the same family as phototherapy, also called LLLT (Low Level Laser Therapy). It can be defined as the directional use of monochromatic or polychromatic light from low energy lasers and / or LEDs, in wavelengths included in the visible, infrared and near infrared, to modulate a function or induce a therapeutic effect in an athermal, non-invasive and non-destructive manner.
This pilot study aims to evaluate the efficacy and safety of this new non-invasive pre-marking device in patients with mild to moderate AD. To date, no study has been published with this device on this typology of patients.
Duration of treatment : 8 weeks with 5 sessions of 25 minutes per week, for a total of 40 sessions.
Study population : Patients with international AD diagnosis criteria according to McKhann et al., 2011 at mild to moderate stage (MMSE score between 16-26), having agreed and signed free and informed consent to participate in this study, without contraindications to the carrying out of the complementary investigations necessary for the evaluation of the efficiency and the tolerance of the RGn530.
Schedule of visits : Each patient will be followed for 3 months at the rate of 5 visits: inclusion V0 (D-10 to D-30), V1 (D0), V2 (M1), V3 (M2) and V4 (M3).
Number of patients : 64 patients will be included in this study: 32 in the photobiomodulation group and 32 in the placebo-sham group.
Duration of patient follow-up : Each patient will be followed for a total duration of 3 months with visits involving clinical, biological, electrophysiological, imaging, tests and questionnaires to assess the efficacy and tolerance of RGn530.
- Conditions
- Alzheimer Disease
- Being tested
- Photobiomodulation REGEnLIFE RGn530 device, SHAM REGEnLIFE RGn530 device
- Keywords
- Alzheimer's Disease, Photobiomodulation, Innovative Therapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation REGEnLIFE RGn530 deviceDevice
For the photobiomodulation group the device is set up and activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective
SHAM REGEnLIFE RGn530 deviceDevice
For the photobiomodulation group the device is set up and not activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation REGEnLIFE RGn530 device group | Experimental | Not described Receives: Device: Photobiomodulation REGEnLIFE RGn530 device |
| Sham REGEnLIFE RGn530 device group | Sham comparator | Not described Receives: Device: SHAM REGEnLIFE RGn530 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orientation (time and space) score (10 items) from the Mini Mental Scale Examination (MMSE)
Mini Mental State Examination (MMSE) is a global cognition assessment (score between 0-30) Folstein MF, Folstein SE, McHugh PR. "Mini Mental State" a practical method for grading the cognitive state of patients for the clinicians. J Psychiat Res. 1975;12:189-19.
Measured: Month 2
Sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall) from the Free and Cued Selective Reminding Test (FCSRT)
Free Cued Selective Remainding Test (FCRST) is a memory test
- Grober E, Sanders AE, Hall C, Lipton RB. Free and cued selective reminding identifies very mild dementia in primary care. Alzheimer Dis Assoc Disord. 2010;24:284-90. ; 2. Mélissa Dion, Olivier Potvin, Sylvie Belleville, Guylaine Ferland, Mélanie Renaud, Louis Bherer, Sven Joubert, Guillaume T. Vallet, Martine Simard, Isabelle Rouleau, Sarah Lecomte, Joël Macoir \& Carol Hudon (2014): Normative Data for the Rappel libre/Rappel indicé à 16 items (16-item Free and Cued Recall) in the Elderly Quebec-French Population, The Clinical Neuropsychologist ; 3. Van der Linden et al. L'épreuve de rappel libre / rappel indicé à 16 items (RL/RI-16), 2004
Measured: Month 2
(3) Digit symbol Substitution test (WAIS-IV coding test)
Digit symbol Substitution test (WAIS-IV coding test) is an executive function assessment (score between 0-135)
1.Wechsler, D., Kaplan, E., Fein, D., Kramer, J., Morris, R., Delis, D., \& Maelender, A. (2003). Wechsler intelligence scale for children: Fourth edition (WISC-IV) [Assessment instrument]. San Antonio, TX; Pearson
Measured: Month 2
(4) 2-minutes Category naming test
Category naming test (CNT) is a language test
1.Cardebat D, Doyon B, Puel M, Goulet P, Joanette Y. Formal and semantic lexical evocation in normal subjects. Performance and dynamics of production as a function of sex, age and educational level. Acta Neurol Belg 1990
Measured: Month 2
Secondary outcomes (34)
MATTIS
MATTIS Dementia Rating Scale (MDRS) is a global cognitive assessment (score between 0-144)
- Schmidt R, Freidl W, Fazekas F, Reinhart B, Grieshofer P, Koch M, et al. The Mattis Dementia Rating Scale. Normative data from 1,001 healthy volunteers. Neurology. 1994;44:964-6. ; 2. Monica Lavoie , Brandy Callahan , Sylvie Belleville , Martine Simard , Nathalie Bier , Lise Gagnon , Jean-François Gagnon , Sophie Blanchet , Olivier Potvin , Carol Hudon \& Joël Macoir (2013) Normative Data for the Dementia Rating Scale-2 in the French-Quebec Population, The Clinical Neuropsychologist, 27:7, 1150-1166
Measured: Month 3
Trail Making Test A and B
Cognitive Assessment
Measured: Month 3
ADAS-Cog
Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) is a global cognitive assessment (score between 0-70)
- Doraiswamy PM, Krishen A, Stallone F, Martin WL, Potts NL, Metz A, et al. Cognitive performance on the Alzheimer's Disease Assessment Scale: effect of education. Neurology. 1995;45:1980-4. ; 2. 1.Mohs et al. Development of Cognitive Instruments fort Use in Clinical Trials of Antidementia Drgus : Adiitions to the Alzheimer's Disease Assessment Scale That Broaden Its Scope, 1997
Measured: Month 3
Clinical Dementia Rating
Clinical Dementia Rating (CDR) score, Questionnaire assessing general well-being, cognitive function (score between 0-5)
- Morris, J. C. (1997). Clinical dementia rating: a reliable and valid diagnostic and staging measure for dementia of the Alzheimer type. International psychogeriatrics, 9(S1), 173-176. ; 2. HUGONOT-DIENER L. La consultation de gériatrie. Masson. 2001
Measured: Month 3
IADL 8 items
Instrumental Activities Of Daily Living (IADL) scale, Questionnaire assessing general autonomy (between 0-8) Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179-86.
Measured: Month 3
Biological Parameters in blood
Level of blood plasma marker Hemoglobin (g/dL)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Erythrocytes (1012/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Platelets (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Leukocytes (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Neutrophilic Polynuclear (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Polynuclear Eosinophils (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Polynuclear Basophils (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Lymphocytes (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Monocytes (109/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Glycemia (blood glucose) (mmol/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Total Cholesterol (mmol/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker HDL Cholesterol (mmol/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker LDL Cholesterol (mmol/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Triglycérides (g/L)
Measured: Month 2
Biological Parameters in blood
Level of marker Serum Glutamate Pyruvate Transaminase (SGPT) (UI/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Creatinine (µmol/ L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker C reactive protein (mg/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Thyroid Stimulating Hormon (TSH) (µUI/mL)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Cobalamin (B12 Vitamin) (ng/L)
Measured: Month 2
Biological Parameters in blood
Level of blood plasma marker Folates (µg/L)
Measured: Month 2
Biological Parameters in CSF
Level of CSF marker protein Aβ42 (pg/ml) Level of CSF marker protein Aβ40 (pg/ml) Level of CSF marker protein Tau (pg/ml) Level of CSF marker protein P-tau (pg/ml)
Measured: Month 2
Electrophysiological Parameter
Wave P300, cerebral activity at 300ms after a stimulus. Analysis of the Amplitude (µV) of the Event-Related Potential (ERP) according to standardized protocol
Measured: Month 2
Electrophysiological Parameter
Wave P300, cerebral activity at 300ms after a stimulus. Analysis of the Latency (ms) of the Event-Related Potential (ERP) according to standardized protocol
Measured: Month 2
Electrophysiological Parameter
Wave P300, cerebral activity at 300ms after a stimulus. Analysis of the antero-posterior gradient (µV) of the Event-Related Potential (ERP) according to standardized protocol
Measured: Month 2
Actimetry Activity Parameter
Activity parameter measuring by alternating plot daytime activity / nocturnal rest, througt an Actimetry Device. The patient will wear actigraphy bracelet during 10 days that will enable to record its movements. The report based on the recording will provide an assessment of night sleep duration.
Measured: Month 2
Actimetry Activity Parameter
Activity parameter measuring by alternating plot daytime activity / nocturnal rest, througt an Actimetry Device. The patient will wear actigraphy bracelet during 10 days that will enable to record its movements. The report based on the recording will provide an assessment of sleep efficiency.
Measured: Month 2
Actimetry Activity Parameter
Activity parameter measuring by alternating plot daytime activity / nocturnal rest, througt an Actimetry Device. The patient will wear actigraphy bracelet during 10 days that will enable to record its movements. The report based on the recording will provide an assessment of daytime somnolence
Measured: Month 2
Morphological MRI 1.5T hippocampal Scheltens volumetry
Imaging
Measured: Month 2
Imaging Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) values in regions of interest
To determine if after the treatment, patients with Alzheimer's disease will have changes in regions of interest
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start7 Sep 2018
- Primary completion13 May 2020
- Study completion13 May 2020
Why it stopped: Covid19 sanitary crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672474
- Sponsor's protocol ID
- RECHMPL18_0075
- Other IDs
- 2018-A00404-51
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Safety and Efficacy of a Photobiomodulation Prototype, REGEnLIFE RGn530 Device, on Cognitive Performances Evolution From Mild-to-moderate Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT03672474
- Acronym / sponsor ID
- RECHMPL18_0075
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Photobiomodulation, Innovative Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid19 sanitary crisis
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REGEnLIFE RGn530 is a photobiomodulation medical device, consisting in a modular helmet and abdominal panel, composed of near-infrared low-level lasers (LLLT), near-infrared and red LEDs as well as a static magnetic field. RGn device application on both head and abdomen have demonstrated striking efficacy in preclinical studies. The investigator's results clearly indicated that RGn treatment produces a normalization of all parameters that are strongly modified in the model, including memory performances associated to oxidative stress, neuroinflammation or apoptosis markers, microbiota composition and specific markers related to the amyloid or tau processes (Blivet et al., Alzheimers Dement (NY), 2018).
Following such promising results, this pilot clinical study will evaluate the safety and efficacy of REGEnLIFE RGn530 device on cognitive performances evolution from mild-to-moderate Alzheimer's disease patients. The double-blind, randomized, monocentric sham-controlled clinical trial will be performed at the CHU de Montpellier. 64 patients will be enrolled: 32 in photobiomodulation group and 32 in sham group. Each patient will follow 8 weeks of treatment with 5 sessions of 25min per week (total of 40 sessions) and will undergo, for a total period of three months, series of clinical examinations including cognitive evaluation, biological and electrophysiological analyses, sleep recordings, and imaging assessments.
REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective. In the light of anti-amyloid therapeutic approaches lack of success, RGn530 dual treatment is hoped to be particularly valuable as an innovative and extensive treatment strategy for AD.
Detailed description
Design : Prospective monocentric double-blind pilot study with 2 parallel groups of 32 patients. One with photobiomodulation (device set up and activated), the other with placebo-sham procedure (device set up but not activated). The study will consist of an inclusion visit (V0, D-30 to D-10), a photobiomodulation start visit (V1, D0), followed by 3 follow-up visits (V2 to D30, V3 to D60 and V4 to D90).
Dispositive : Photobiomodulation device developed by REGEnLIFE, RGn530 consisting of a modular helmet and an abdominal modular panel each comprising modules composed of low intensity infrared lasers (LLLT - Low Level Laser Therapy), infrared and red LEDs and a static magnetic field. The helmet and abdominal panel devices are connected to a steering console. Activation of the device will be done by personnel trained for this purpose by REGEnLIFE.
Originality and innovation : This study proposes to evaluate a new medical photobiomodulation device in the field of neurodegenerative diseases. These techniques have shown positive and promising results in the following areas: wound healing, pain management, inflammation, tissue regeneration, and the following disciplines: neuropsychiatry, dermatology and neurology.
Photobiomodulation is a technology of the same family as phototherapy, also called LLLT (Low Level Laser Therapy). It can be defined as the directional use of monochromatic or polychromatic light from low energy lasers and / or LEDs, in wavelengths included in the visible, infrared and near infrared, to modulate a function or induce a therapeutic effect in an athermal, non-invasive and non-destructive manner.
This pilot study aims to evaluate the efficacy and safety of this new non-invasive pre-marking device in patients with mild to moderate AD. To date, no study has been published with this device on this typology of patients.
Duration of treatment : 8 weeks with 5 sessions of 25 minutes per week, for a total of 40 sessions.
Study population : Patients with international AD diagnosis criteria according to McKhann et al., 2011 at mild to moderate stage (MMSE score between 16-26), having agreed and signed free and informed consent to participate in this study, without contraindications to the carrying out of the complementary investigations necessary for the evaluation of the efficiency and the tolerance of the RGn530.
Schedule of visits : Each patient will be followed for 3 months at the rate of 5 visits: inclusion V0 (D-10 to D-30), V1 (D0), V2 (M1), V3 (M2) and V4 (M3).
Number of patients : 64 patients will be included in this study: 32 in the photobiomodulation group and 32 in the placebo-sham group.
Duration of patient follow-up : Each patient will be followed for a total duration of 3 months with visits involving clinical, biological, electrophysiological, imaging, tests and questionnaires to assess the efficacy and tolerance of RGn530.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation REGEnLIFE RGn530 device group | Experimental | Device: Photobiomodulation REGEnLIFE RGn530 device |
| Sham REGEnLIFE RGn530 device group | Sham comparator | Device: SHAM REGEnLIFE RGn530 device |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and/or Female ;
- Age between 55-85 years old ;
- Diagnostic of AD according to international criteria of McKhann et al., 2011 [1] ;
- Mild-to-moderate Alzheimer's disease stage with MMSE score between 16 and 26 ;
- Symptomatic treatments specific to AD (Memantine, acetylcholinesterase inhibitors) and pyshotropic treatments (anxiolytics, anti-depressants, neuroleptics) are allowed but must be maintained at fixed doses during the 4 weeks previous to inclusion and during all the study length ;
Key exclusion criteria (16 listed)
- Clinical and paraclinical details insufficient for AD diagnostic ;
- Genetic form of AD (genetic mutation characterized) ;
- No caregiver to complete neuropsychological scales and evaluation forms ;
- Patient living in a medical institution ;
- Illiteracy or inability to perform psycho-behavioral tests ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation REGEnLIFE RGn530 deviceFor the photobiomodulation group the device is set up and activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective | Device | Photobiomodulation REGEnLIFE RGn530 device group |
| SHAM REGEnLIFE RGn530 deviceFor the photobiomodulation group the device is set up and not activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective | Device | Sham REGEnLIFE RGn530 device group |
Primary outcome
Orientation (time and space) score (10 items) from the Mini Mental Scale Examination (MMSE)
Time frame: Month 2
Mini Mental State Examination (MMSE) is a global cognition assessment (score between 0-30) Folstein MF, Folstein SE, McHugh PR. "Mini Mental State" a practical method for grading the cognitive state of patients for the clinicians. J Psychiat Res. 1975;12:189-19.
Sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall) from the Free and Cued Selective Reminding Test (FCSRT)
Time frame: Month 2
Free Cued Selective Remainding Test (FCRST) is a memory test 1. Grober E, Sanders AE, Hall C, Lipton RB. Free and cued selective reminding identifies very mild dementia in primary care. Alzheimer Dis Assoc Disord. 2010;24:284-90. ; 2. Mélissa Dion, Olivier Potvin, Sylvie Belleville, Guylaine Ferland, Mélanie Renaud, Louis Bherer, Sven Joubert, Guillaume T. Vallet, Martine Simard, Isabelle Rouleau, Sarah Lecomte, Joël Macoir \& Carol Hudon (2014): Normative Data for the Rappel libre/Rappel indicé à 16 items (16-item Free and Cued Recall) in the Elderly Quebec-French Population, The Clinical Neuropsychologist ; 3. Van der Linden et al. L'épreuve de rappel libre / rappel indicé à 16 items (RL/RI-16), 2004
(3) Digit symbol Substitution test (WAIS-IV coding test)
Time frame: Month 2
Digit symbol Substitution test (WAIS-IV coding test) is an executive function assessment (score between 0-135) 1.Wechsler, D., Kaplan, E., Fein, D., Kramer, J., Morris, R., Delis, D., \& Maelender, A. (2003). Wechsler intelligence scale for children: Fourth edition (WISC-IV) [Assessment instrument]. San Antonio, TX; Pearson
(4) 2-minutes Category naming test
Time frame: Month 2
Category naming test (CNT) is a language test 1.Cardebat D, Doyon B, Puel M, Goulet P, Joanette Y. Formal and semantic lexical evocation in normal subjects. Performance and dynamics of production as a function of sex, age and educational level. Acta Neurol Belg 1990
34 secondary outcomes
MATTIS
Time frame: Month 3
Trail Making Test A and B
Time frame: Month 3
ADAS-Cog
Time frame: Month 3
Clinical Dementia Rating
Time frame: Month 3
IADL 8 items
Time frame: Month 3
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in blood
Time frame: Month 2
Biological Parameters in CSF
Time frame: Month 2
Electrophysiological Parameter
Time frame: Month 2
Electrophysiological Parameter
Time frame: Month 2
Electrophysiological Parameter
Time frame: Month 2
Actimetry Activity Parameter
Time frame: Month 2
Actimetry Activity Parameter
Time frame: Month 2
Actimetry Activity Parameter
Time frame: Month 2
Morphological MRI 1.5T hippocampal Scheltens volumetry
Time frame: Month 2
Imaging Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) values in regions of interest
Time frame: Change from baseline at 3 months
Results and safety
The study was stopped early (reason given: Covid19 sanitary crisis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Aging
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation REGEnLIFE RGn530 device in people with Alzheimer Disease, run by University Hospital, Montpellier at 1 site 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Covid19 sanitary crisis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orientation (time and space) score (10 items) from the Mini Mental Scale Examination (MMSE) (time frame: Month 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025; AzTrials last refreshed its copy on 5 Nov 2026.