Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study

Background: Alzheimer’s disease’s (AD) prevalence is projected to increase as the population ages and current treatments are minimally effective. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates into the cerebral cortex, stimulates the mitochondrial respiratory chain...

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Main Authors: Dan V. Iosifescu, Xiaotong Song, Maia B. Gersten, Arwa Adib, Yoonju Cho, Katherine M. Collins, Kathy F. Yates, Aura M. Hurtado-Puerto, Kayla M. McEachern, Ricardo S. Osorio, Paolo Cassano
Format: Article
Language:English
Published: MDPI AG 2023-07-01
Series:Healthcare
Subjects:
Online Access:https://www.mdpi.com/2227-9032/11/14/2017
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author Dan V. Iosifescu
Xiaotong Song
Maia B. Gersten
Arwa Adib
Yoonju Cho
Katherine M. Collins
Kathy F. Yates
Aura M. Hurtado-Puerto
Kayla M. McEachern
Ricardo S. Osorio
Paolo Cassano
author_facet Dan V. Iosifescu
Xiaotong Song
Maia B. Gersten
Arwa Adib
Yoonju Cho
Katherine M. Collins
Kathy F. Yates
Aura M. Hurtado-Puerto
Kayla M. McEachern
Ricardo S. Osorio
Paolo Cassano
author_sort Dan V. Iosifescu
collection DOAJ
description Background: Alzheimer’s disease’s (AD) prevalence is projected to increase as the population ages and current treatments are minimally effective. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates into the cerebral cortex, stimulates the mitochondrial respiratory chain, and increases cerebral blood flow. Preliminary data suggests t-PBM may be efficacious in improving cognition in people with early AD and amnestic mild cognitive impairment (aMCI). Methods: In this randomized, double-blind, placebo-controlled study with aMCI and early AD participants, we will test the efficacy, safety, and impact on cognition of 24 sessions of t-PBM delivered over 8 weeks. Brain mechanisms of t-PBM in this population will be explored by testing whether the baseline tau burden (measured with <sup>18</sup>F-MK6240), or changes in mitochondrial function over 8 weeks (assessed with <sup>31</sup>P-MRSI), moderates the changes observed in cognitive functions after t-PBM therapy. We will also use changes in the fMRI Blood-Oxygenation-Level-Dependent (BOLD) signal after a single treatment to demonstrate t-PBM-dependent increases in prefrontal cortex blood flow. Conclusion: This study will test whether t-PBM, a low-cost, accessible, and user-friendly intervention, has the potential to improve cognition and function in an aMCI and early AD population.
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spelling doaj.art-4e9d65be0a2545faac12e9752648bbd72023-11-18T19:32:45ZengMDPI AGHealthcare2227-90322023-07-011114201710.3390/healthcare11142017Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) StudyDan V. Iosifescu0Xiaotong Song1Maia B. Gersten2Arwa Adib3Yoonju Cho4Katherine M. Collins5Kathy F. Yates6Aura M. Hurtado-Puerto7Kayla M. McEachern8Ricardo S. Osorio9Paolo Cassano10Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY 10962, USADepartment of Psychiatry, New York University Grossman School of Medicine, New York, NY 10016, USADepartment of Psychiatry, Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA 02129, USADepartment of Psychiatry, New York University Grossman School of Medicine, New York, NY 10016, USADepartment of Psychiatry, Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA 02129, USANathan S. Kline Institute for Psychiatric Research, Orangeburg, NY 10962, USANathan S. Kline Institute for Psychiatric Research, Orangeburg, NY 10962, USADepartment of Psychiatry, Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA 02129, USADepartment of Psychiatry, Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA 02129, USANathan S. Kline Institute for Psychiatric Research, Orangeburg, NY 10962, USADepartment of Psychiatry, Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA 02129, USABackground: Alzheimer’s disease’s (AD) prevalence is projected to increase as the population ages and current treatments are minimally effective. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates into the cerebral cortex, stimulates the mitochondrial respiratory chain, and increases cerebral blood flow. Preliminary data suggests t-PBM may be efficacious in improving cognition in people with early AD and amnestic mild cognitive impairment (aMCI). Methods: In this randomized, double-blind, placebo-controlled study with aMCI and early AD participants, we will test the efficacy, safety, and impact on cognition of 24 sessions of t-PBM delivered over 8 weeks. Brain mechanisms of t-PBM in this population will be explored by testing whether the baseline tau burden (measured with <sup>18</sup>F-MK6240), or changes in mitochondrial function over 8 weeks (assessed with <sup>31</sup>P-MRSI), moderates the changes observed in cognitive functions after t-PBM therapy. We will also use changes in the fMRI Blood-Oxygenation-Level-Dependent (BOLD) signal after a single treatment to demonstrate t-PBM-dependent increases in prefrontal cortex blood flow. Conclusion: This study will test whether t-PBM, a low-cost, accessible, and user-friendly intervention, has the potential to improve cognition and function in an aMCI and early AD population.https://www.mdpi.com/2227-9032/11/14/2017Alzheimer’s disease (AD)transcranial photobiomodulation (t-PBM)neuromodulationcognitionfunctional MRI (fMRI)Phosphorus magnetic resonance spectroscopic imaging (31P-MRSI)
spellingShingle Dan V. Iosifescu
Xiaotong Song
Maia B. Gersten
Arwa Adib
Yoonju Cho
Katherine M. Collins
Kathy F. Yates
Aura M. Hurtado-Puerto
Kayla M. McEachern
Ricardo S. Osorio
Paolo Cassano
Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
Healthcare
Alzheimer’s disease (AD)
transcranial photobiomodulation (t-PBM)
neuromodulation
cognition
functional MRI (fMRI)
Phosphorus magnetic resonance spectroscopic imaging (31P-MRSI)
title Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
title_full Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
title_fullStr Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
title_full_unstemmed Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
title_short Protocol Report on the Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD) Study
title_sort protocol report on the transcranial photobiomodulation for alzheimer s disease trap ad study
topic Alzheimer’s disease (AD)
transcranial photobiomodulation (t-PBM)
neuromodulation
cognition
functional MRI (fMRI)
Phosphorus magnetic resonance spectroscopic imaging (31P-MRSI)
url https://www.mdpi.com/2227-9032/11/14/2017
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