REGEnLIFE RGn530 - Feasibility Pilot

NCT03672474 | Terminated

• 2 other identifiers: RECHMPL18_00752018-A00404-51
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Photobiomodulation; Innovative Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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 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

  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

  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

  Month 2

Secondary Outcomes (34)

• MATTIS

  Month 3

• Trail Making Test A and B

  Month 3

• ADAS-Cog

  Month 3

• Clinical Dementia Rating

  Month 3

• IADL 8 items

  Month 3

Study Arms (2)

Photobiomodulation REGEnLIFE RGn530 device group

EXPERIMENTAL

Device: Photobiomodulation REGEnLIFE RGn530 device

Sham REGEnLIFE RGn530 device group

SHAM COMPARATOR

Device: SHAM REGEnLIFE RGn530 device

Interventions

Photobiomodulation REGEnLIFE RGn530 device DEVICE

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

Photobiomodulation REGEnLIFE RGn530 device group

SHAM REGEnLIFE RGn530 device DEVICE

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

Sham REGEnLIFE RGn530 device group

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 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 ;
• Patient approval for biological, eletrophysiological and imaging tests ;
• Enough availability to participate daily to the proposed treatment sessions ;
• 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 ;

You may not qualify if:

• 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
• 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) ;

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital, Gui de Chauliac

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 14, 2018
• Study Start: September 7, 2018
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: September 30, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)