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

August 31, 2023 updated by: Danyang Huichuang Medical Equipment Co., Ltd.
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
    • Sichuan
      • Chongqing, Sichuan, China, 400000
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: treatment group
active setting
Device: treatment group-Device: NirsCure - Active NirsCure - Active settings
Treatment was performed once a day,5-6 times a week for 16 weeks.
Placebo Comparator: Control group
sham setting
Device: placebo group-Device: NirsCure - Sham NirsCure - Sham settings
Treatment was performed once a day,5-6 times a week for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in ADAS-cog
Time Frame: 8 weeks, 16 weeks and 24 weeks
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
Time Frame: 8 weeks, 16 weeks and 24 weeks
(Mini-Mental State Examination, MMSE ;The higher the score, the better.
8 weeks, 16 weeks and 24 weeks
Change from baseline in ALFF
Time Frame: 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.
8 weeks, 16 weeks and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in MOCA
Time Frame: 8 weeks, 16 weeks and 24 weeks
Montreal Cognitive Assessment, MoCA；The higher the score, the better.
8 weeks, 16 weeks and 24 weeks
Change from baseline in ADCS-CGIC
Time Frame: 8 weeks, 16 weeks and 24 weeks
Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC
8 weeks, 16 weeks and 24 weeks
Change from baseline in ADCS-ADL
Time Frame: 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.
8 weeks, 16 weeks and 24 weeks
Change from baseline in NPI
Time Frame: 8 weeks, 16 weeks and 24 weeks
Neuropaychiatic Inventory，NPI；The higher the score, the worse.
8 weeks, 16 weeks and 24 weeks
Change from baseline in HAMD
Time Frame: 8 weeks, 16 weeks and 24 weeks
Hamilton depression scale,HAMD; The higher the score, the worse.
8 weeks, 16 weeks and 24 weeks
Aβ amyloid and tau levels
Time Frame: 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.
8 weeks, 16 weeks and 24 weeks
MRI
Time Frame: 8 weeks, 16 weeks and 24 weeks
Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.
8 weeks, 16 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danyang Huichuang Medical Equipment Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital of Chongqing Medical University
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ping Ze Lv, Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018YFC2001700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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