Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease

Mild to Moderate Alzheimer's Disease Clinical Trial

Official title:

Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06008639
• Other study ID #: 2018YFC2001700
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Danyang Huichuang Medical Equipment Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate Alzheimer's Disease

Intervention

Device:
• treatment group-Device: NirsCure - Active NirsCure - Active settings
Treatment was performed once a day,5-6 times a week for 16 weeks.
• placebo group-Device: NirsCure - Sham NirsCure - Sham settings
Treatment was performed once a day,5-6 times a week for 16 weeks.

Locations

Country	Name	City	State
China	Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids	Beijing	Beijing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
Danyang Huichuang Medical Equipment Co., Ltd.	First Affiliated Hospital of Chongqing Medical University, Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in MMSE	(Mini-Mental State Examination, MMSE ;The higher the score, the better.	8 weeks, 16 weeks and 24 weeks
Primary	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
Secondary	Change from baseline in MOCA	Montreal Cognitive Assessment, MoCA;The higher the score, the better.	8 weeks, 16 weeks and 24 weeks
Secondary	Change from baseline in ADCS-CGIC	Alzheimer's Disease Cooperative study-clinical global impression of change scale,ADCS-CGIC	8 weeks, 16 weeks and 24 weeks
Secondary	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
Secondary	Change from baseline in NPI	Neuropaychiatic Inventory,NPI;The higher the score, the worse.	8 weeks, 16 weeks and 24 weeks
Secondary	Change from baseline in HAMD	Hamilton depression scale,HAMD; The higher the score, the worse.	8 weeks, 16 weeks and 24 weeks
Secondary	Aß amyloid and tau levels	Plasma Aß 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
Secondary	MRI	Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.	8 weeks, 16 weeks and 24 weeks