Multisensory 40-Hz Stimulation for Alzheimer's Disease
A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease
Přehled studie
Postavení
Podmínky
Detailní popis
Alzheimer's disease is associated with abnormalities in neural network activity and gamma-frequency oscillations. Preclinical studies suggest that sensory stimulation at 40 Hz may entrain gamma oscillations and influence Alzheimer's disease-related pathological and functional changes.
This single-center, prospective, randomized, sham-controlled study will investigate the safety and preliminary efficacy of combined auditory and visual 40-Hz stimulation in participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia. Eligible participants will have evidence of Alzheimer's disease pathology based on positron emission tomography, cerebrospinal fluid, or blood biomarkers.
Participants will be randomly assigned in a 1:1 ratio to active multisensory 40-Hz stimulation or sham stimulation. Both interventions will be administered for 60 minutes once daily for 4 weeks. Clinical assessments, electroencephalography, multimodal magnetic resonance imaging, and blood biomarkers will be obtained at baseline and after completion of the intervention. Clinical assessments, electroencephalography, and blood biomarkers will also be collected at 3 and 6 months after treatment to assess the durability of treatment effects. Safety will be evaluated through the incidence and severity of adverse events throughout the intervention and follow-up periods.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jinhui Yin, MD
- Telefonní číslo: +8619801177703
- E-mail: yjh_hw@163.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Provision of written informed consent by the participant or the participant's legally authorized representative.
- Age 45 to 75 years, inclusive.
- Completion of at least primary school education.
- Diagnosis within the Alzheimer's disease spectrum according to the National 5.Institute on Aging and Alzheimer's Association criteria.
Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, defined by a Montreal Cognitive Assessment score of ≤24 for participants with middle school education or above, or ≤23 for participants with primary school education, and a Clinical Dementia Rating global score of 0.5 or 1.
6.Evidence of Alzheimer's disease pathology based on a positive positron emission tomography, cerebrospinal fluid, or blood biomarker result.
7.Alzheimer's disease-related medications are expected to remain stable during the study period.
Exclusion Criteria:
- Current or previous history of a neurological disorder other than Alzheimer's disease that may affect cognition or study assessments, including epilepsy, stroke, multiple sclerosis, poorly controlled migraine, intracranial injury, previous neurosurgery, or head trauma with residual neurological impairment.
- Contraindication to magnetic resonance imaging, electroencephalography, auditory stimulation, visual stimulation, or noninvasive brain stimulation.
- Current major depressive disorder or another psychiatric disorder that, in the investigator's judgment, may interfere with study participation or outcome assessment.
- Clinically significant structural abnormalities on brain magnetic resonance imaging, including hydrocephalus, stroke, or another structural lesion that may confound study results.
- Severe cardiovascular or pulmonary disease.
- Cognitive impairment primarily attributable to another disorder, including frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease dementia, or vascular dementia.
- Clinically significant suicide risk or a suicide attempt within the previous 12 months.
- Behavioral disturbance, including severe aggression, agitation, or impulsivity, that may interfere with adherence to study procedures.
- Current or planned treatment with an anti-amyloid monoclonal antibody during the study period.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Active Multisensory 40-Hz Stimulation
|
A device delivering synchronized auditory and visual stimulation at a frequency of 40 Hz.
Each intervention session will last 60 minutes and will be administered once daily for 4 consecutive weeks.
|
|
Falešný srovnávač: Sham Multisensory Stimulation
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The sham device will reproduce the appearance, setup, and duration of the active intervention but will not deliver synchronized 40-Hz auditory and visual stimulation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score
Časové okno: Baseline to 1 week after completion of the 4-week intervention
|
The Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item version assesses cognitive performance in domains including memory, language, and praxis.
Total scores range from 0 to 70, with higher scores indicating greater cognitive impairment.
Change from baseline will be calculated as the post-intervention score minus the baseline score.
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Baseline to 1 week after completion of the 4-week intervention
|
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Incidence of Treatment-Emergent Adverse Events
Časové okno: From the first intervention session through 6 months after completion of the intervention
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Number and proportion of participants experiencing one or more treatment-emergent adverse events from the first intervention session through completion of follow-up.
Adverse events will be graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
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From the first intervention session through 6 months after completion of the intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
Časové okno: Baseline to 1 week after completion of the 4-week intervention
|
Change in resting-state electroencephalographic power within the predefined gamma-frequency band following the intervention.
Gamma-band power will be calculated using a prespecified electroencephalographic preprocessing and spectral analysis pipeline.
|
Baseline to 1 week after completion of the 4-week intervention
|
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Change From Baseline in Montreal Cognitive Assessment Score
Časové okno: Baseline to 1 week after completion of the 4-week intervention
|
The Montreal Cognitive Assessment evaluates global cognitive function.
Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
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Baseline to 1 week after completion of the 4-week intervention
|
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Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
Časové okno: Baseline to 1 week after completion of the 4-week intervention
|
Plasma phosphorylated tau 217 concentration will be measured in fasting blood samples using a prespecified validated assay.
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Baseline to 1 week after completion of the 4-week intervention
|
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Glymphatic MRI marker
Časové okno: Baseline to 1 week after completion of the 4-week intervention
|
The DTI-ALPS index will be calculated from diffusion magnetic resonance imaging as a noninvasive imaging marker related to water diffusivity along perivascular spaces.
|
Baseline to 1 week after completion of the 4-week intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yue Huang, Beijing Tiantan Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HX-A-2025116
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- MÍZA
- CSR
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