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| Name | Class |
|---|---|
| Danyang Huichuang Medical Equipment Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core phase: sham irradiation group. | Sham Comparator |
| |
| Core phase: Near infrared light therapy | Experimental |
| |
| Extension phase: Near infrared light therapy | Experimental | This arm includes participants who finish the core phase from the core phase experimental group and the core phase sham comparator group. The intervention is the same as the intervention in the core phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NirsCure | Device | True near-infrared light； Once a day, once for 30 minutes, 6 times a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Tang, MD., PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | 100053 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| sham NirsCure | Device | 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 |
|
| NirsCure | Device | True near-infrared light； Once a day, once for 30 minutes, 6 times a week |
|
| 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) | 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) | 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) | 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) | 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) | 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 | baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks. |
| Change from Baseline in FDG-PET imaging | 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) | 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 | 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 | 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. | baseline, 8 weeks,16 weeks, 52 weeks, 76 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |