Transcranial Near-infrared Light Therapy for Mild-Moderate Alzheimer's Disease

The Safety and Efficacy of Transcranial Near-infrared Light in the Treatment of Mild-Moderate Alzheimer's Disease

The goal of this study is to explore the efficacy and safety of Near-infrared light Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD).

This study will employ a randomized,blind,parallel controlled approach.Qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment; The subjects who entered the control group received 30 minutes of non near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Device: sham NirsCure-9000 series; Device: NirsCure-9000 series

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Tang, MD., PhD; Phone Number: 00861083199456; Email: tangyi@xwhosp.org
• Study Contact Backup: Name: Liyang Liu, MD; Phone Number: 00861083192332; Email: slioliu@pku.edu.cn

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Yi Tang, M.D., Ph.D.; Phone Number: 00861083199456; Email: tangyixw@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 50 - 90 years old, no gender limitation;
2. Meeting clinical diagnostic criteria of probable AD according to National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
3. Clinical Dementia Rating Scale Total Score (CDR-GS) score ≥ 1 and ≤ 2, Clinical Dementia Rating Scale Memory Box score ≥ 0.5;
4. Amyloid PET or cerebrospinal fluid examination conforms to changes in AD biomarkers;
5. The MMSE score is ≥ 12 and ≤ 26;
6. Education level is non illiterate or has received cultural education for 4-6 years or more;
7. If taking mental or cognitive improvement drugs, the dosage must be stable for at least 3 months before the study, and remain unchanged during the light regulation intervention period. Unless otherwise specified, participants must consistently use all other (i.e. non Alzheimer's disease related) permitted concomitant medications for at least 4 weeks before baseline;
8. Having a designated guardian or caregiver who can assist them in participating in the experiment (defined as someone who can support participants throughout the entire study period and spend at least 8 hours with them per week);
9. Subjects with informed consent;

Exclusion Criteria:

1. Any neurological and psychiatric symptoms beyond the scope of symptoms that can be caused by Alzheimer's disease;
2. A history of transient ischemic attack (TIA), stroke, or epilepsy within 12 months;
3. Any mental diagnosis or symptoms that may interfere with the participant's research process (such as hallucinations, severe depression, or delusions);
4. Contraindications to MRI, including pacemakers/defibrillators, ferromagnetic metal implants, etc;
5. MRI shows other clinically significant lesions, which may indicate the diagnosis of dementia beyond Alzheimer's disease;
6. MRI shows other important pathological findings, including but not limited to: 4 or more microbleeds with a diameter of 10 millimeters or less; Single bleeding lesion with a maximum diameter greater than 10 millimeters; Surface iron deposition area; Evidence of exudative edema; Evidence of brain contusion, encephalomalacia, aneurysm, vascular malformation, or infectious disease; Multiple lacunar infarcts or strokes involving major vascular areas, severe small vessel or white matter lesions; Space occupying lesions; Or brain tumors (diagnosed as meningiomas or arachnoid cysts, lesions with a maximum diameter of less than 1 cm may not be ruled out);
7. A photosensitive response to sunlight or visible light, with eczema or increased sensitivity on the skin at the intervention site;
8. Severe visual or hearing impairment;
9. Individuals who are addicted to alcohol, drugs, or other drugs or have a tendency to become addicted;
10. Participating in other AD clinical trials;
11. Any other medical conditions that are not stable and adequately controlled (such as heart, respiratory, gastrointestinal, kidney diseases), or situations that the researcher believes may affect the safety of participants or interfere with the evaluation of the study;
12. Other conditions that, in the opinion of the investigator, may not be suitable for this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham irradiation group.	Device: sham NirsCure-9000 series; Non near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week
Experimental: Near infrared light group	Device: NirsCure-9000 series; true near infrared light；Once a day, once for 30 minutes, 6 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)	baseline, 8 weeks, 8 weeks post treatment
change from baseline on the Mini Mental state Examination (MMSE) score	baseline,8 weeks,16 weeks,8 weeks post treatment
change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)	baseline,8 weeks,16 weeks,8 weeks post treatment
change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)	baseline,8 weeks,16 weeks,8 weeks post treatment
hange from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)	baseline,8 weeks,16 weeks,8 weeks post treatment
change from baseline on the Neuropaychiatic Inventory (NPI)	baseline,8 weeks,16 weeks,8 weeks post treatment
change from baseline on the Hamilton depression scale (HAMD)	baseline,8 weeks,16 weeks,8 weeks post treatment
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan	baseline,16 weeks
Change from Baseline in FDG-PET imaging	baseline,16 weeks
Change from Baseline in resting state near-infrared brain function imaging	baseline,8 weeks,16 weeks,8 weeks post treatment
Change from Baseline in resting state functional nuclear magnetic resonance low-frequency fluctuation amplitude (ALFF) analysis by functional Magnet Resonance Imaging	baseline,16 weeks
Change from Baseline in resting state Electroencephalogram and Event Related Potentials (ERP)	baseline,8 weeks,16 weeks,8 weeks post treatment

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Danyang Huichuang Medical Equipment Co., Ltd.
• Investigators: Principal Investigator: Yi Tang, MD., PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2023162

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