PMID- 36189591
OWN - NLM
STAT- MEDLINE
DCOM- 20221115
LR  - 20221129
IS  - 1875-8908 (Electronic)
IS  - 1387-2877 (Linking)
VI  - 90
IP  - 2
DP  - 2022
TI  - A Randomized, Double-Blind, and Sham-Controlled Trial of an Innovative Brain-Gut 
      Photobiomodulation Therapy: Safety and Patient Compliance.
PG  - 811-822
LID - 10.3233/JAD-220467 [doi]
AB  - BACKGROUND: Recent innovative non-pharmacological interventions and 
      neurostimulation devices have shown potential for application in the treatment of 
      Alzheimer's disease (AD). These include photobiomodulation (PBM) therapy. 
      OBJECTIVE: This pilot study assesses the safety, compliance with, and efficacy of 
      a brain-gut PBM therapy for mild-to-moderate AD patients. METHODS: This 
      double-blind, randomized, monocentric sham-controlled study started in 2018 and 
      ended prematurely in 2020 due to the COVID-19 pandemic. Fifty-three 
      mild-to-moderate AD patients were randomized, 27 in the PBM group and 26 in the 
      sham group. All patients had 40 treatment sessions lasting 25 min each over 8 
      weeks and were followed for 4 weeks afterwards. Compliance with the treatment was 
      recorded. Safety was assessed by recording adverse events (AEs), and efficacy was 
      evaluated using neuropsychological tests. RESULTS: The PBM therapy proved to be 
      safe in regard to the number of recorded AEs (44% of the patients), which were 
      balanced between the PBM and sham groups. AEs were mainly mild, and no serious 
      AEs were reported. The majority of the patients (92.5%) were highly compliant, 
      which confirms the feasibility of the PBM treatment. Compared to the sham 
      patients, the PBM patients showed lower ADAS-Cog comprehension subscores, higher 
      forward verbal spans, and lower TMT-B execution times, which suggests an 
      improvement in cognitive functions. CONCLUSION: This study demonstrates the 
      tolerability of and patient compliance with a PBM-based treatment for 
      mild-to-moderate AD patients. It highlights encouraging efficacy trends and 
      provides insights for the design of the next phase trial in a larger AD patient 
      sample.
FAU - Blivet, Guillaume
AU  - Blivet G
AD  - REGEnLIFE, Montpellier, France.
FAU - Relano-Gines, Aroa
AU  - Relano-Gines A
AD  - REGEnLIFE, Montpellier, France.
FAU - Wachtel, Melanie
AU  - Wachtel M
AD  - ICTA PM, Fontaine-Les-Dijon, France.
FAU - Touchon, Jacques
AU  - Touchon J
AD  - University of Montpellier, France.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Alzheimers Dis
JT  - Journal of Alzheimer's disease : JAD
JID - 9814863
SB  - IM
MH  - Humans
MH  - *Low-Level Light Therapy
MH  - Pilot Projects
MH  - Pandemics
MH  - Treatment Outcome
MH  - *COVID-19
MH  - *Alzheimer Disease/radiotherapy/drug therapy
MH  - Brain
MH  - Double-Blind Method
MH  - Patient Compliance
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - brain-gut axis
OT  - cognition
OT  - dementia
OT  - memory
OT  - neurodegenerative diseases
OT  - optics and photonics
OT  - photobiomodulation
EDAT- 2022/10/04 06:00
MHDA- 2022/11/16 06:00
CRDT- 2022/10/03 05:50
PHST- 2022/10/04 06:00 [pubmed]
PHST- 2022/11/16 06:00 [medline]
PHST- 2022/10/03 05:50 [entrez]
AID - JAD220467 [pii]
AID - 10.3233/JAD-220467 [doi]
PST - ppublish
SO  - J Alzheimers Dis. 2022;90(2):811-822. doi: 10.3233/JAD-220467.