An Early Phase 1 interventional study of NirsCure with Lecanemab and sham NirsCure with Lecanemab in Alzheimer Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Xuanwu Hospital, Beijing · Early Phase 1, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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Exclusion Criteria:
Other: NirsCure with Lecanemab
Other: sham NirsCure with Lecanemab
This arm includes participants who finish the core phase and are willing to take part in the extension phase.
Other: NirsCure with Lecanemab
Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).
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).
Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
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.
Time frame: 16 weeks.
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
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.
Time frame: 32 weeks, 48 weeks.
The change from baseline in the Mini-Mental State Examination (MMSE).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Neuropsychiatric Inventory (NPI).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Hamilton Depression Rating Scale (HAMD).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline levels measured by Positron Emission Tomography (PET).
Time frame: 16 weeks, 48 weeks.
The change from baseline as measured by Magnetic Resonance Imaging (MRI).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in blood biomarker measurements.
Concentration of Abeta-40, Abeta-42, t-tau, p-tau181, p-tau217, GFAP, NFL
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline as measured by EEG power across different frequency bands.
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.
Time frame: 16 weeks, 32 weeks, 48 weeks.
Safety indicators/adverse events.
Time frame: 16 weeks, 32 weeks, 48 weeks.
Plan to share: No
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Xuanwu Hospital, Beijing