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

Primary Purpose

Mild to Moderate Alzheimer's Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
treatment group-Device: NirsCure - Active NirsCure - Active settings
placebo group-Device: NirsCure - Sham NirsCure - Sham settings
Sponsored by
Danyang Huichuang Medical Equipment Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
  • The First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment group

Control group

Arm Description

active setting

sham setting

Outcomes

Primary Outcome Measures

Change from baseline in ADAS-cog
Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog;The higher the score, the worse.
Change from baseline in MMSE
(Mini-Mental State Examination, MMSE ;The higher the score, the better.
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.

Secondary Outcome Measures

Change from baseline in MOCA
Montreal Cognitive Assessment, MoCA;The higher the score, the better.
Change from baseline in ADCS-CGIC
Alzheimer's Disease Cooperative study-clinical global impression of change scale,ADCS-CGIC
Change from baseline in ADCS-ADL
Alzheimer's Disease Cooperative study-Activities of Daily Living Scale,ADCS-ADL;The higher the score, the better.
Change from baseline in NPI
Neuropaychiatic Inventory,NPI;The higher the score, the worse.
Change from baseline in HAMD
Hamilton depression scale,HAMD; The higher the score, the worse.
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.
MRI
Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.

Full Information

First Posted
June 15, 2023
Last Updated
August 31, 2023
Sponsor
Danyang Huichuang Medical Equipment Co., Ltd.
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, First Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06008639
Brief Title
Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease
Official Title
Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danyang Huichuang Medical Equipment Co., Ltd.
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, First Affiliated Hospital of Chongqing Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
active setting
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
sham setting
Intervention Type
Device
Intervention Name(s)
treatment group-Device: NirsCure - Active NirsCure - Active settings
Intervention Description
Treatment was performed once a day,5-6 times a week for 16 weeks.
Intervention Type
Device
Intervention Name(s)
placebo group-Device: NirsCure - Sham NirsCure - Sham settings
Intervention Description
Treatment was performed once a day,5-6 times a week for 16 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in ADAS-cog
Description
Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog;The higher the score, the worse.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in MMSE
Description
(Mini-Mental State Examination, MMSE ;The higher the score, the better.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in ALFF
Description
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.
Time Frame
8 weeks, 16 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in MOCA
Description
Montreal Cognitive Assessment, MoCA;The higher the score, the better.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in ADCS-CGIC
Description
Alzheimer's Disease Cooperative study-clinical global impression of change scale,ADCS-CGIC
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in ADCS-ADL
Description
Alzheimer's Disease Cooperative study-Activities of Daily Living Scale,ADCS-ADL;The higher the score, the better.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in NPI
Description
Neuropaychiatic Inventory,NPI;The higher the score, the worse.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Change from baseline in HAMD
Description
Hamilton depression scale,HAMD; The higher the score, the worse.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
Aβ amyloid and tau levels
Description
Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better.
Time Frame
8 weeks, 16 weeks and 24 weeks
Title
MRI
Description
Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.
Time Frame
8 weeks, 16 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Ze Lv
Organizational Affiliation
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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