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NCT Number: NCT06992804

Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

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

This study will employ a randomized, double-blind, sham-controlled method with an open-label extension phase. This trial contains the core phase and an extension phase. During the core phase, eligible subjects were selected and randomized (experimental group: control group = 1:1). The subjects who entered the experimental group received treatment with a near-infrared light therapy device combined with lecanemab for 16 weeks. The subjects who entered the control group received treatment with a near-infrared light therapy device simulator (sham stimulation) combined with lecanemab for 16 weeks. After completing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants were treated with a near-infrared light therapy device combined with lecanemab up to week 48.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location status: Recruiting

Location contact

Yi Tang, MD, PhD

CONTACT

[email protected]

00861083199456

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 50 and 90 years old, gender unrestricted;
  • Meet the core clinical diagnostic criteria for probable Alzheimer's disease as defined by the National Institute on Aging and the Alzheimer's Association (2011 NIA-AA);
  • Amyloid positivity confirmed by Amyloid PET;
  • Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
  • Mini-Mental State Examination (MMSE) score ≥ 15;
  • Participants must have an educational level of primary school or above and be capable of completing the cognitive assessments and other tests as specified in the protocol;
  • If taking cognition-enhancing medications, the dosage must have been stable for at least 12 weeks prior to enrollment (psychotropic drug dosage stable for at least 4 weeks);
  • The participant or their guardian voluntarily agrees to participate and signs the informed consent form.
  • For caregivers, the following requirements must be met: They need to be stable and have the ability to read. A minimum of 1 hour of daily interaction with the participant is necessary. Throughout the study, they are expected to assist in completing the informant sections of the scale assessments. Additionally, they should be willing to help the participant use the near-infrared light therapy device. Finally, they must understand and agree to the study procedures.

Exclusion criteria

  • Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
  • APOE genotype of ε4/ε4;
  • More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
  • Currently taking anticoagulant medications;
  • History of epilepsy or hemorrhagic stroke within the past 12 months;
  • Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;
  • Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);
  • Malignant tumors;
  • Any unstable and uncontrolled medical conditions (such as severe cardiac, respiratory, gastrointestinal, renal diseases), or conditions that the investigator deems may affect the safety of the patient or interfere with trial assessments;
  • Contraindications to PET or MRI, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants, etc.;
  • Currently receiving anti-amyloid treatment for Alzheimer's disease with severe adverse reactions such as cerebral hemorrhage or cerebral edema;
  • Alcohol or drug addiction;
  • Pregnant, breastfeeding, or planning to become pregnant;
  • Participation in another clinical study within one month prior to this trial;
  • Other situations deemed by the investigator as unsuitable for participation in the clinical study.
  • For caregivers, the following exclusion criterion applies: They must not have severe neurological or psychiatric disorders.

Treatment and study plan

NirsCure with Lecanemab

Other

Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).

sham NirsCure with Lecanemab

Other

Sham near-infrared light therapy (where only the equipment appearance is consistent with the true near infrared light device, one session per day, 30 minutes per session, 6 sessions per week) in combined with lecanemab (10mg/kg).

Primary outcomes

  1. The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).

    Time frame: 16 weeks.

    The Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog-14) is a comprehensive tool used to evaluate cognitive function in individuals. The unabbreviated scale title is the Alzheimer's Disease Assessment Scale - Cognitive Section. The minimum score on this scale is 0, while the maximum score is 144. Importantly, higher scores on the ADAS-Cog-14 indicate worse cognitive function. This scale assesses various cognitive domains, and an increasing score reflects more severe cognitive impairment.

Secondary outcomes

  1. The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).

    Time frame: 32 weeks, 48 weeks.

    The Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog-14) is a comprehensive tool used to evaluate cognitive function in individuals. The unabbreviated scale title is the Alzheimer's Disease Assessment Scale - Cognitive Section. The minimum score on this scale is 0, while the maximum score is 144. Importantly, higher scores on the ADAS-Cog-14 indicate worse cognitive function. This scale assesses various cognitive domains, and an increasing score reflects more severe cognitive impairment.

  2. The change from baseline in the Mini-Mental State Examination (MMSE).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function. The unabbreviated scale title is the Mini-Mental State Examination. The minimum score on this scale is 0, while the maximum score is 30. Higher scores on the MMSE indicate better cognitive function. This scale evaluates various cognitive domains such as orientation, attention, calculation, recall, and language. A higher score reflects better cognitive performance.

  3. The change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Clinical Dementia Rating - Sum of Boxes (CDR-SB) is a comprehensive assessment tool used to evaluate the severity of dementia. The unabbreviated scale title is the Clinical Dementia Rating - Sum of Boxes. The minimum score on this scale is 0, while the maximum score is 18. Higher scores on the CDR-SB indicate worse cognitive and functional impairment. This scale assesses various domains including memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. An increasing score reflects more severe dementia.

  4. The change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) is a tool designed to assess the functional abilities of individuals in their daily activities. The unabbreviated scale title is the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale. The minimum score on this scale is 0, while the maximum score is 78. Higher scores on the ADCS-ADL indicate better functional ability in daily living activities. This scale evaluates various aspects of daily living, such as personal care, household chores, and financial management. A higher score reflects better performance in activities of daily living.

  5. The change from baseline in the Neuropsychiatric Inventory (NPI).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Neuropsychiatric Inventory (NPI) is a comprehensive assessment tool used to evaluate behavioral and psychiatric symptoms in individuals with cognitive disorders. The unabbreviated scale title is the Neuropsychiatric Inventory. The minimum score on this scale is 0, while the maximum score is 144. Higher scores on the NPI indicate more severe behavioral and psychiatric symptoms. This scale assesses various domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, and motor disturbance. An increasing score reflects more significant behavioral and psychiatric disturbances.

  6. The change from baseline in the Hamilton Depression Rating Scale (HAMD).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Hamilton Depression Rating Scale (HAMD) is a widely used tool for assessing the severity of depressive symptoms in individuals. The unabbreviated scale title is the Hamilton Depression Rating Scale. The minimum score on this scale is 0, while the maximum score is 52 (for the 17-item version). Higher scores on the HAMD indicate more severe depressive symptoms. This scale evaluates various aspects of depression, including mood, guilt, suicide, insomnia, agitation, anxiety, somatic symptoms, and weight loss. An increasing score reflects more significant depressive symptomatology.

  7. The change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a tool used to assess the overall change in clinical status of individuals with Alzheimer's disease. The unabbreviated scale title is the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change. The scale ranges from 1 to 7, with 1 indicating "Very much improved" and 7 indicating "Very much worse." A score of 4 represents "No change." Lower scores on the ADCS-CGIC indicate better clinical outcomes, reflecting improvement or stabilization, while higher scores indicate worsening clinical status. This scale provides a global assessment of change based on the clinician's judgment of the patient's overall condition.

  8. The change from baseline levels measured by Positron Emission Tomography (PET).

    Time frame: 16 weeks, 48 weeks.

  9. The change from baseline as measured by Magnetic Resonance Imaging (MRI).

    Time frame: 16 weeks, 32 weeks, 48 weeks.

  10. The change from baseline in blood biomarker measurements.

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    Concentration of Abeta-40, Abeta-42, t-tau, p-tau181, p-tau217, GFAP, NFL

  11. The change from baseline as measured by EEG power across different frequency bands.

    Time frame: 16 weeks, 32 weeks, 48 weeks.

    This outcome measure assesses changes in EEG power across different frequency bands, including Delta (1-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), Beta (12-30 Hz), and Gamma (30-100 Hz). EEG recordings will be taken at baseline and at specified time points during the study to evaluate changes in brain activity.

    Power: µV²/Hz

    Higher power in specific frequency bands may indicate increased brain activity, while lower power may suggest decreased activity. The clinical significance of changes in EEG power will be interpreted based on the study objectives and relevant clinical standards.

  12. Safety indicators/adverse events.

    Time frame: 16 weeks, 32 weeks, 48 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Liyang Liu, MD

CONTACT

[email protected]

00861083192332

Yi Tang, MD, PhD

CONTACT

[email protected]

00861083199456

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
May 28, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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