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| Name | Class |
|---|---|
| Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids | UNKNOWN |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Active Comparator | active setting |
|
| Control group | Placebo Comparator | sham setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment group-Device: NirsCure - Active NirsCure - Active settings | Device | Treatment was performed once a day,5-6 times a week for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ADAS-cog | Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog;The higher the score, the worse. | 8 weeks, 16 weeks and 24 weeks |
| Change from baseline in MMSE | (Mini-Mental State Examination, MMSE ;The higher the score, the better. | 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. | 8 weeks, 16 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MOCA | Montreal Cognitive Assessment, MoCA;The higher the score, the better. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Ze Lv | Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids | Beijing | Beijing Municipality | 100000 | China |
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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.
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| placebo group-Device: NirsCure - Sham NirsCure - Sham settings | Device | Treatment was performed once a day,5-6 times a week for 16 weeks. |
|
| 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. | 8 weeks, 16 weeks and 24 weeks |
| Change from baseline in NPI | Neuropaychiatic Inventory,NPI;The higher the score, the worse. | 8 weeks, 16 weeks and 24 weeks |
| Change from baseline in HAMD | Hamilton depression scale,HAMD; The higher the score, the worse. | 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. | 8 weeks, 16 weeks and 24 weeks |
| MRI | Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed. | 8 weeks, 16 weeks and 24 weeks |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Sichuan | 400000 | China |