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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160908
• Other study ID #: 2023162
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Yi Tang, MD., PhD
• Phone: 00861083199456
• Email: tangyi[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• NirsCure-9000 series
true near infrared light;Once a day, once for 30 minutes, 6 times a week
• 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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Danyang Huichuang Medical Equipment Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)		16 weeks
Secondary	change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)		baseline, 8 weeks, 8 weeks post treatment
Secondary	change from baseline on the Mini Mental state Examination (MMSE) score		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	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
Secondary	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
Secondary	change from baseline on the Neuropaychiatic Inventory (NPI)		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	change from baseline on the Hamilton depression scale (HAMD)		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan		baseline,16 weeks
Secondary	Change from Baseline in FDG-PET imaging		baseline,16 weeks
Secondary	Change from Baseline in resting state Electroencephalogram and Event Related Potentials (ERP)		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	Change from Baseline in resting state near-infrared brain function imaging		baseline,8 weeks,16 weeks,8 weeks post treatment
Secondary	Change from Baseline in resting state functional nuclear magnetic resonance low-frequency fluctuation amplitude (ALFF) analysis by functional Magnet Resonance Imaging		baseline,16 weeks