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

NCT06008639 | Unknown DMC

• 1 other identifier: 2018YFC2001700
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Mild to Moderate Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Change from baseline in MOCA

  8 weeks, 16 weeks and 24 weeks

• Change from baseline in ADCS-CGIC

  8 weeks, 16 weeks and 24 weeks

• Change from baseline in ADCS-ADL

  8 weeks, 16 weeks and 24 weeks

• Change from baseline in NPI

  8 weeks, 16 weeks and 24 weeks

• Change from baseline in HAMD

  8 weeks, 16 weeks and 24 weeks

Study Arms (2)

treatment group

ACTIVE COMPARATOR

active setting

Device: treatment group-Device: NirsCure - Active NirsCure - Active settings

Control group

PLACEBO COMPARATOR

sham setting

Device: placebo group-Device: NirsCure - Sham NirsCure - Sham settings

Interventions

treatment group-Device: NirsCure - Active NirsCure - Active settings DEVICE

Treatment was performed once a day,5-6 times a week for 16 weeks.

treatment group

placebo group-Device: NirsCure - Sham NirsCure - Sham settings DEVICE

Treatment was performed once a day,5-6 times a week for 16 weeks.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danyang Huichuang Medical Equipment Co., Ltd.: lead
• Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (2)

Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Sichuan, 400000, China

Location

Study Officials

• Ping Ze Lv

  Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 23, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)