The goal of this study is to explore the efficacy and safety of Near-infrared light Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD). This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and extension phase. In the core phase, qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment. The subjects who entered the control group received 30 minutes of non-near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks. After finishing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants receive active near-infrared light therapy until week 196.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
True near-infrared light； Once a day, once for 30 minutes, 6 times a week
Non near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week
True near-infrared light； Once a day, once for 30 minutes, 6 times a week
Xuanwu Hospital, Capital Medical University
Beijing, China
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: 16 weeks
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: baseline, 8 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Mini Mental state Examination (MMSE) score
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Neuropaychiatic Inventory (NPI)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Hamilton depression scale (HAMD)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan
Time frame: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in FDG-PET imaging
Time frame: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in resting state Electroencephalogram and Event Related Potentials (ERP)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in resting state near-infrared brain function imaging
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks.
Change from Baseline in magnetic resonance imaging analysis
Time frame: baseline, 8 weeks,16 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from baseline in blood biomarkers.
Time frame: baseline, 8 weeks,16 weeks, 52 weeks, 76 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
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