Mild to Moderate Alzheimer's Disease
Conditions
Brief summary
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
Interventions
DEVICEtreatment group-Device: NirsCure - Active NirsCure - Active settings
Treatment was performed once a day,5-6 times a week for 16 weeks.
DEVICEplacebo group-Device: NirsCure - Sham NirsCure - Sham settings
Treatment was performed once a day,5-6 times a week for 16 weeks.
Sponsors
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
First Affiliated Hospital of Chongqing Medical University
Danyang Huichuang Medical Equipment Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The age of registration is 50-85 years old, male or female. * The MMSE score \< 26 points can be used to complete the scale assessment. * Patients who are not on medication and who are taking psychotropic or cognitive-improving drugs must have a stable dose for at least 12 weeks before the trial and remain the same for the duration of treatment. * Agree to participate in the clinical trial, willing to maintain the original treatment plan during the trial, and have signed the informed consent
Exclusion criteria
* MRI showed evidence of abnormalities other than Alzheimer's disease, such as cerebral infarction at key sites and severe leukodystrophy (Fezakas\>Level 3). * There are contraindications to MRI scanning, such as metal implants, claustrophobia, etc. * A history of stroke or seizures. * Photosensitive to sunlight or visible light, eczema or increased sensitivity of the skin at the treatment site. * Severe vision or hearing impairment. * Alcohol dependence, drug or other drug addiction or addiction tendency. * During the study , subjects were pregnant, breastfeeding, or planning to pregnancy. * He/She is currently participating in another study related to the treatment of AD. * Researchers think that participants could not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ADAS-cog | 8 weeks, 16 weeks and 24 weeks | Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse. |
| Change from baseline in MMSE | 8 weeks, 16 weeks and 24 weeks | (Mini-Mental State Examination, MMSE ;The higher the score, the better. |
| Change from baseline in ALFF | 8 weeks, 16 weeks and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in NPI | 8 weeks, 16 weeks and 24 weeks | Neuropaychiatic Inventory，NPI；The higher the score, the worse. |
| Change from baseline in HAMD | 8 weeks, 16 weeks and 24 weeks | Hamilton depression scale,HAMD; The higher the score, the worse. |
| Change from baseline in MOCA | 8 weeks, 16 weeks and 24 weeks | Montreal Cognitive Assessment, MoCA；The higher the score, the better. |
| MRI | 8 weeks, 16 weeks and 24 weeks | Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed. |
| Aβ amyloid and tau levels | 8 weeks, 16 weeks and 24 weeks | Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better. |
| Change from baseline in ADCS-CGIC | 8 weeks, 16 weeks and 24 weeks | Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC |
| Change from baseline in ADCS-ADL | 8 weeks, 16 weeks and 24 weeks | Alzheimer's Disease Cooperative study-Activities of Daily Living Scale，ADCS-ADL;The higher the score, the better. |
Countries
China
Outcome results
None listed