A Pilot Study of Near-Infrared Light Treatment for Alzheimer’s Disease

Article type: Research Article

Authors: Chen, Liang^{a; b; c; d; e; 1} | Xue, Jun^{a; b; c; d; e; 1} | Zhao, Qianhua^{f; g} | Liang, Xiaoniu^{f; g} | Zheng, Li^{f; g} | Fan, Zhen^{a; b; c; d; e} | Souare, Ibrahima Sory Jnr^{a; b; c; d; e} | Suo, Yuanzhen^h | Wei, Xunbinⁱ | Ding, Ding^{f; g} | Mao, Ying^{a; b; c; d; e; *}

Affiliations: [a] Department of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China | [b] National Center for Neurological Disorders, Shanghai, China | [c] Shanghai Key Laboratory of Brain Function and Restoration and Neural Regeneration, Shanghai, China | [d] Neurosurgical Institute of Fudan University, Shanghai, China | [e] Shanghai Clinical Medical Center of Neurosurgery, Shanghai, China | [f] Institute of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China | [g] National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China | [h] Biomedical Pioneering Innovation Center, Peking University, Beijing, China | [i] Department of Biomedical Engineering, Peking University, Beijing, China

Correspondence: [*] Correspondence to: Ying Mao, Department of Neurosurgery, Huashan Hospital, Fudan University, Wulumuqi Zhong Road 12, Shanghai, 200040, China. Tel.: +8602152889999; E-mail: [email protected].

Note: [1] These authors contributed equally to this work.

Abstract: Background:Laboratory investigations have demonstrated that near-infrared (NIR) light treatment can reduce amyloid-β burden in models of Alzheimer’s disease (AD). However, previous clinical studies are rather insufficient. Objective:Before starting a large-scale clinical trial, we performed a pilot study to characterize the efficacy of NIR light for AD patients. Methods:Twenty participants with mild to moderate AD were assigned randomly to the intervention (1060-1080 nm and 800-820 nm NIR light treatment for 12 weeks) or control group (without sham treatment). Safety and efficacy were evaluated at baseline, week 4, 8, and 12, and 4 weeks after treatment. Results:In the intervention and control groups at week 12, mean changes from baseline on the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) were -3.1 and -1.3 (p = 0.5689). Mean changes from baseline on the Activities of Daily Living (ADL) were -3.6 versus 3.1 (p = 0.0437). Mean changes from baseline on the Mini-Mental State Examination (MMSE) were 4.4 versus 1.0 (p = 0.0253). The percentage of participants who exhibited a change larger than 4 points from baseline to week 12 was determined for the intervention and control groups on the ADAS-Cog (57% versus 29%), ADL (29% versus 0%), and MMSE (57% versus 14%). Treatment with NIR light did not increase the incidence of adverse events in participants. Conclusion:NIR light treatment appears to be safe and potentially beneficial for AD patients. It improved cognitive function and activities of daily living. The preliminary data encouraged us to launch a large-sample, multicenter, double-blind clinical trial.

Keywords: Alzheimer’s disease, clinical study, cognition, pilot project, physical therapy

DOI: 10.3233/JAD-220866

Journal: Journal of Alzheimer's Disease, vol. 91, no. 1, pp. 191-201, 2023