Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)

经颅光生物调节治疗阿尔茨海默病 (TRAP-AD)

• 批准号: 10612738
• 负责人: PAOLO CASSANO
• 金额: $ 80.83万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10612738
• 关键词: Acute; Adenosine Triphosphate; Adverse event; Age; Alzheimer disease prevention; Alzheimer' s Disease; Animal Model; Antioxidants; Bilateral; Bioenergetics; Biological Markers; Blood flow; Brain; Brain Pathology; Case Series; Cephalic; Cerebral cortex; Cerebrovascular Circulation; Clinical; Cognition; Cognitive deficits; Data; Dementia; Devices; Disease Progression; Dose; Double-Blind Method; Early Intervention; Electrodes; Electroencephalography; Feeling suicidal; Forehead; Functional Magnetic Resonance Imaging; Future; General Hospitals; Goals; Human; Individual; Intervention; Lasers; Light; Literature; Major Depressive Disorder; Massachusetts; Measures; Mediator; Memory; Metabolic Pathway; Mitochondria; Monitor; Neuropsychological Tests; Neuropsychology; New York; Oxidative Phosphorylation; Parkinson Disease; Participant; Patients; Penetration; Phase; Physiologic pulse; Population; Positioning Attribute; Positron-Emission Tomography; Prefrontal Cortex; Prevalence; Production; Randomized; Randomized, Controlled Trials; Reactive Oxygen Species; Reporting; Respiratory Chain; Safety; Signal Transduction; Site; Symptoms; Technology; Testing; Universities; Vitamins; absorption; acute stroke; amnestic mild cognitive impairment; antidepressant effect; biomarker development; biomarker validation; blood oxygen level dependent; clinical development; cognitive function; cost; cytochrome c oxidase; dietary supplements; dosage; efficacy evaluation; efficacy outcomes; efficacy testing; glucose metabolism; improved; innovation; magnetic resonance spectroscopic imaging; neuroimaging; neuroregulation; novel; photobiomodulation; pre-clinical; primary outcome; prodromal Alzheimer' s disease; randomized, clinical trials; secondary outcome; sleep quality; stroke patient; tau Proteins; therapeutic target; treatment effect; treatment response; user-friendly

PROJECT SUMMARY The prevalence of Alzheimer disease (AD) is projected to increase as the population ages, and current treatments are only minimally effective. Recently, emphasis has been placed on understanding and treating the factors that influence early brain pathology in order to slow the ultimate clinical expression of AD. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates robustly into the cerebral cortex, stimulating the mitochondrial respiratory chain, and also significantly increases cerebral blood flow (CBF). Early data suggests t-PBM may be efficacious in improving cognitive deficits in early AD and in amnestic mild cognitive impairment (aMCI). This project aims to test, in a randomized controlled trial, the efficacy and safety of 24 sessions of t-PBM, delivered over 8 weeks and compared to sham, in improving clinical symptoms of aMCI. Additionally, we will explore the brain mechanisms of t-PBM in aMCI, by testing whether baseline tau burden (measured with 18F-MK6240), or changes in mitochondrial function measures over 8 weeks (measured by 31P-MRSI) moderate the changes observed in cognitive functions after t-PBM therapy. We will also use changes in fMRI blood-oxygenation-level dependent (BOLD) after a single treatment, to demonstrate t-PBM-dependent increases in prefrontal cortex (PFC) cortical blood flow (CBF). The study will be done in parallel at New York University, Nathan Kline Institute and at Massachusetts General Hospital. The importance of this study is threefold: (1) it targets aMCI, an important prodromal stage of AD, which lacks adequate approved treatments, (2) it evaluates the efficacy and safety of t-PBM, an innovative, non-invasive technology which has a well-established safety profile, for improving brain function and cognition at the prodromal AD stages, and, (3) explores the association of t-PBM treatment effects with important biomarkers relevant for AD illness progression. If effects are confirmed, the present study will both support short-term clinical development of an easy to scale device for the treatment of aMCI and AD, while also validating biomarkers for the development of future, novel modulation strategies.

项目总结