To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease. Each subject will be numbered and their medical records will be established. The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Treatment was performed once a day,5-6 times a week for 16 weeks.
Treatment was performed once a day,5-6 times a week for 16 weeks.
Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Sichuan, China
Change from baseline in ADAS-cog
Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse.
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in MMSE
(Mini-Mental State Examination, MMSE ;The higher the score, the better.
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in ALFF
The amplitudeof low-frequency fluctuations, ALFF;The increase of ALFF indicates that neuronal excitability and metabolism are enhanced, while the decrease of ALFF indicates that neuronal spontaneous activity is inhibited.
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in MOCA
Montreal Cognitive Assessment, MoCA；The higher the score, the better.
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in ADCS-CGIC
Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in ADCS-ADL
Alzheimer's Disease Cooperative study-Activities of Daily Living Scale，ADCS-ADL;The higher the score, the better.
Time frame: 8 weeks, 16 weeks and 24 weeks
Change from baseline in NPI
Neuropaychiatic Inventory，NPI；The higher the score, the worse.
Time frame: 8 weeks, 16 weeks and 24 weeks
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Change from baseline in HAMD
Hamilton depression scale,HAMD; The higher the score, the worse.
Time frame: 8 weeks, 16 weeks and 24 weeks
Aβ amyloid and tau levels
Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better.
Time frame: 8 weeks, 16 weeks and 24 weeks
MRI
Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.
Time frame: 8 weeks, 16 weeks and 24 weeks