Terapeutické zařízení s blízkým infračerveným zářením pro mírnou až středně těžkou Alzheimerovu chorobu (NirsCure-03A)
Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie účinnosti a bezpečnosti zařízení pro terapii blízkým infračerveným světlem u účastníků s mírnou až středně těžkou Alzheimerovou chorobou (NirsCure-03A)
This study is a multicenter, randomized, double-blind, sham-device-controlled clinical trial.
A total of 320 patients with mild to moderate Alzheimer's disease (AD) are planned to be enrolled. Central stratified block randomization will be applied, with stratification based on disease severity (mild vs. moderate) and Aβ-PET subgroup center status (yes vs. no). Participants will be randomly assigned to either the treatment group or control group in a 1:1 ratio. After enrollment, participants will complete the treatment at home during a 52-week double-blind period. The treatment group will receive therapy using a near-infrared light therapy device, while the control group will use sham device. Both investigators and participants will remain blinded to treatment allocation throughout the double-blind period. Participants who complete the 52-week double-blind treatment period may choose to enter an open-label extension and receive an additional 26 weeks of active near-infrared light therapy.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Yi Tang, MD, PhD
- Telefonní číslo: +86 13811021432
- E-mail: tangyi@xwhosp.org
Studijní místa
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100191
- Nábor
- Peking University Third Hospital
-
Kontakt:
- Weizhong Xiao, MD, PhD
- Telefonní číslo: +86 15611908691
-
Beijing, Beijing Municipality, Čína, 100053
- Nábor
- Xuanwu Hospital, Capital Medical University
-
Kontakt:
- Yi Tang, MD, PhD
- Telefonní číslo: +86 13811021432
- E-mail: tangyi@xwhosp.org
-
Beijing, Beijing Municipality, Čína, 100032
- Nábor
- Peking University First Hospital
-
Kontakt:
- Yongan Sun, MD, PhD
- Telefonní číslo: +86 13391705678
-
Beijing, Beijing Municipality, Čína, 100730
- Nábor
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
-
Kontakt:
- Jing Yuan, MD, PhD
- Telefonní číslo: +86 18601105034
-
Beijing, Beijing Municipality, Čína, 100050
- Nábor
- Beijing Friendship Hospital, Capital Medical University
-
Kontakt:
- Yongbo Zhang, MD, PhD
- Telefonní číslo: +86 13552909549
-
-
Hebei
-
Shijiazhuang, Hebei, Čína, 050000
- Nábor
- Shijiazhuang People's Hospital
-
Kontakt:
- Jianping Zhang, MD, PhD
- Telefonní číslo: +86 17603116783
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Čína, 014040
- Nábor
- Baotou Central Hospital
-
Kontakt:
- Furu Liang, MD, PhD
- Telefonní číslo: +86 13664077877
-
-
Jiangsu
-
Suzhou, Jiangsu, Čína, 215006
- Nábor
- The First Affiliated Hospital of Soochow University
-
Kontakt:
- Qun Xue, MD, PhD
- Telefonní číslo: +86 13013813620
-
Suzhou, Jiangsu, Čína, 215004
- Nábor
- The Second Affiliated Hospital of Soochow University
-
Kontakt:
- Chunfeng Liu, MD, PhD
- Telefonní číslo: +86 13606210609
-
-
Shaanxi
-
Xi'an, Shaanxi, Čína, 710061
- Nábor
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Kontakt:
- Jin Wang, MD, PhD
- Telefonní číslo: +86 13572208524
-
Xi'an, Shaanxi, Čína, 710068
- Nábor
- Shaanxi Provincial People's Hospital
-
Kontakt:
- Rui Li, MD, PhD
-
Xi'an, Shaanxi, Čína, 710038
- Nábor
- Tangdu Hospital, Air Force Medical University
-
Kontakt:
- Wei Zhang, MD， PhD
- Telefonní číslo: +86 13891955100
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200127
- Nábor
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
-
Kontakt:
- Qun Xu, MD, PhD
- Telefonní číslo: +86 13301679717
-
Shanghai, Shanghai Municipality, Čína, 200040
- Nábor
- Huashan Hospital, Fudan University
-
Kontakt:
- Qianhua Zhao, MD, PhD
-
Shanghai, Shanghai Municipality, Čína, 200030
- Nábor
- Shanghai Mental Health Center
-
Kontakt:
- Xia Li, MD, PhD
- Telefonní číslo: +86 13774272543
-
Shanghai, Shanghai Municipality, Čína, 201399
- Nábor
- Pudong Hospital, Fudan University
-
Kontakt:
- Yunxia Li, MD, PhD
- Telefonní číslo: +86 13636370312
-
-
Shanxi
-
Taiyuan, Shanxi, Čína, 030001
- Nábor
- The First Hospital of Shanxi Medical University
-
Kontakt:
- Yang Li, MD, PhD
- Telefonní číslo: +86 15035182003
-
Taiyuan, Shanxi, Čína, 030001
- Nábor
- Shanxi Bethune Hospital
-
Kontakt:
- Xiaolei Liu, MD, PhD
- Telefonní číslo: +86 13934643261
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Čína, 300052
- Nábor
- General Hospital, Tianjin Medical University
-
Kontakt:
- Nan Zhang, MD, PhD
- Telefonní číslo: +86 13752128310
-
Tianjin, Tianjin Municipality, Čína, 300060
- Nábor
- Tianjin Huanhu Hospital
-
Kontakt:
- Pan Li, MD, PhD
- Telefonní číslo: +86 13114881943
-
Tianjin, Tianjin Municipality, Čína, 300121
- Nábor
- Tianjin People's Hospital
-
Kontakt:
- Meiyun Zhang, MD, PhD
- Telefonní číslo: +86 13102017703
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310009
- Nábor
- The Second Affiliated Hospital, Zhejiang University School of Medicine
-
Kontakt:
- Baorong Zhang, MD, PhD
- Telefonní číslo: +86 13958167260
-
Hangzhou, Zhejiang, Čína, 310015
- Nábor
- Affiliated Hospital of Hangzhou Normal University
-
Kontakt:
- Jinghua Wang, MD, PhD
- Telefonní číslo: +86 15068892292
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
Male or female participants aged between 50 to 85 years old (inclusive).
-
Participants must have at least 4 years of formal education and be capable of completing cognitive and other protocol-specified assessments.
-
Documented progressive memory decline for ≥12 months prior to screening.
-
Meets the core clinical diagnostic criteria for mild to moderate AD dementia (stages 4-5), according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) 2018 research framework and the AA workgroup 2024 update.
-
Evidence of positive brain amyloid pathology, demonstrated by at least one of the following:
- Positive Aβ-PET scan (historical positive result acceptable); or
- Positive Cerebrospinal fluid (CSF) Aβ testing (historical positive result acceptable).
-
Mini-Mental State Examination (MMSE) total score between 15 and 26 inclusive (between 12 and 22 for participants with an elementary school education level).
-
Clinical Dementia Rating (CDR) Global of 1 or 2, and the CDR-Memory Box scores ≥ 0.5.
-
If receiving acetylcholinesterase inhibitor or memantine, participants must be on a stable dose for at least 12 weeks prior to baseline.
-
Must have at least one reliable study partner who can accompany the participant to complete daily treatment. The study partner should have a close relationship with the participant and sufficient knowledge to accurately report on cognition, function, behavior, safety, and protocol compliance. The study partner must be able to communicate with study staff via phone or WeChat, attend required on-site visit, provide informed consent to supporting follow-up throughout the study.
-
The participant, study partner, or legally authorized representative voluntarily agrees to participate and provides written informed consent prior to any study procedures.
Exclusion Criteria:
-
Presence of any diagnosis other than AD that could cause dementia or cognitive decline, including but not limited to: vascular dementia; Central nervous system infections (e.g., HIV, neurosyphilis); Creutzfeldt-Jakob disease; Huntington's disease; Parkinson's disease; Lewy body dementia; Traumatic brain injury-related dementia; Dementia caused by physical and chemical factors (e.g., drug toxicity, alcohol intoxication, carbon monoxide poisoning); significant systemic diseases (e.g., hepatic or pulmonary encephalopathy); Intracranial space-occupying lesions (e.g., subdural hematoma, brain tumors); or dementia clearly attributable to endocrine disorders, vitamin deficiencies, or other identifiable causes.
-
Brain MRI demonstrating significant pathological findings, including but not limited to:
- More than two infarcts with a diameter > 2 cm, or a single infarct involving critical regions (thalamus, hippocampus, entorhinal cortex, parahippocampal cortex, angular gyrus, or other cortical and subcortical gray matter nuclei);
- Extensive white matter hyperintensities (Fazekas score ≥ 3);
- Space-occupying lesions such as abscesses or brain tumors. Lesions judged by the investigator to have no clear clinical significance do not require exclusion.
-
History of transient ischemic attack (TIA), stroke, or seizure within 6 months of screening.
-
Hachinski Ischemic Score (HIS) > 4.
-
Hamilton Depression Rating Scale (HAMD-17) total score > 10.
-
Diagnosis of a psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) at screening, including schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, or delirium.
-
Known history or laboratory confirmation of HIV infection or neurosyphilis at screening.
-
Severe cardiovascular disease, including New York Heart Association (NYHA) class III or IV heart function; Severe or unstable angina, or newly developed unstable angina within 3 months prior to screening (with objective clinical evidence such as cardiac enzyme abnormalities or dynamic ST-T changes on electrocardiogram); Acute myocardial infarction within 6 months prior to screening.
-
Severe dysfunction of major organs (heart, lungs, liver, kidneys, etc.), or any medical condition that, in the opinion of the investigator, could render the participant unsuitable for this study or interfere with participation.
-
Current or prior treatment with any anti-amyloid monoclonal antibody (e.g., aducanumab, lecanemab, or donanemab).
-
Prior or planned lymphaticovenous anastomosis (LVA) of the cervical deep lymphatic vessels.
-
Participation in any interventional clinical trial involving a drug or medical device within the 30 days prior to screening, except for observational studies or verified placebo-group participation in a previous interventional trial.
-
History of severe head trauma or implanted cranial devices (e.g., bone screws, bone plates, prior cranial surgery, deep brain stimulators); Contraindications to MRI (e.g., claustrophobia, pacemakers/defibrillators, ferromagnetic metal implants); unwilling to undergo MRI examination.
-
Contraindications to PET or allergy to Aβ-PET tracer (except participants enrolled based solely on CSF Aβ positivity). Participants with uncontrolled abnormal blood glucose, allergy to FDG tracer, or any other investigator-judged contraindications are ineligible for the FDG-PET substudy.
-
History of malignancy within 5 years prior to screening, except for:
- Adequately treated basal or squamous cell skin carcinoma, or cervical dysplasia;
- Adequately treated Stage I in situ cervical cancer ≥ 2 years prior to screening without recurrence;
- Prostate cancer confined to the prostate, adequately treated (e.g., surgery, radiotherapy, or active surveillance), with stable prostate-specific antigen (PSA) levels for ≥ 2 years prior to screening;
- Non-metastatic breast cancer, adequately treated and without recurrence.
-
Women who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential not using highly effective contraception.
-
Any other condition that, in the opinion of the investigator, may compromise the participant's safety, interfere with protocol adherence, or confound study results.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Falešný srovnávač: Sham device
Device: NirsCure 6000 sham device (once daily for 30 minutes, six times per week) |
Sham device for 52 weeks during the double-blind period (once daily for 30 minutes, six times per week). Participants entering the open-label extension will receive active near-infrared light therapy for an additional 26 weeks. |
|
Experimentální: Near infrared light therapy
Device: NirsCure 6000 Near-infrared light therapy (once daily for 30 minutes, six times per week) |
Near-infrared light therapy for 52 weeks during the double-blind period (once daily for 30 minutes, six times per week). Participants entering the open-label extension will receive an additional 26 weeks of active treatment with the same regimen. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13)
Časové okno: 52 weeks
|
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) score at 52-Weeks. The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating greater cognitive impairment. |
52 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Integrated Alzheimer's Disease Rating Scale (iADRS)
Časové okno: 52 weeks
|
Change from baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) score at 52-Weeks. The iADRS score ranges from 0 to 144, with higher scores indicating better overall cognitive and functional performance. |
52 weeks
|
|
Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL)
Časové okno: 52 weeks
|
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at 52-Weeks. The ADCS-ADL score ranges from 0 to 78, with higher scores indicating better functional ability in activities of daily living. |
52 weeks
|
|
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Časové okno: 52 weeks
|
Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at 52-Weeks. The CDR-SB score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment. |
52 weeks
|
|
Mini-Mental Status Examination (MMSE)
Časové okno: 52 weeks
|
Change from baseline in Mini-Mental State Examination (MMSE) score at 52-Weeks. The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function. |
52 weeks
|
|
ADAS-Cog13
Časové okno: 13, 26 and 39 weeks
|
Change from baseline in the ADAS-Cog13 at Week 13, 26 and 39 |
13, 26 and 39 weeks
|
|
ADAS-Cog13
Časové okno: 81 weeks
|
Change from baseline in the ADAS-Cog13 at Week 81 |
81 weeks
|
|
iADRS
Časové okno: 81 weeks
|
Change from baseline in the iADRS at Week 81 |
81 weeks
|
|
ADCS-ADL
Časové okno: 81 weeks
|
Change from baseline in the ADCS-ADL at Week 81 |
81 weeks
|
|
CDR-SB
Časové okno: 81 weeks
|
Change from baseline in the CDR-SB at Week 81 |
81 weeks
|
|
MMSE
Časové okno: 81 weeks
|
Change from baseline in the MMSE at Week 81 |
81 weeks
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- NirsCure-03A
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .