Multisensory 40-Hz Stimulation for Alzheimer's Disease
6 août 2026 mis à jour par: huang yue, Beijing Tiantan Hospital
A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease
This study aims to evaluate the safety and preliminary efficacy of combined auditory and visual 40-Hz stimulation in participants with biomarker-confirmed Alzheimer's disease spectrum disorders.
A total of 60 participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia will be randomly assigned in a 1:1 ratio to receive either active multisensory 40-Hz stimulation or sham stimulation.
The intervention will be administered for 60 minutes once daily for 4 consecutive weeks.
Clinical assessments, electroencephalography, multimodal magnetic resonance imaging, and blood biomarkers will be evaluated before and after the intervention.
Additional clinical, electroencephalographic, and blood biomarker assessments will be performed at 3 and 6 months after the intervention.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jinhui Yin, MD
- Numéro de téléphone: +8619801177703
- E-mail: yjh_hw@163.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Comparateur factice: Sham Multisensory Stimulation
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score
Délai: 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.
|
Baseline to 1 week after completion of the 4-week intervention
|
|
Incidence of Treatment-Emergent Adverse Events
Délai: From the first intervention session through 6 months after completion of the intervention
|
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.
|
From the first intervention session through 6 months after completion of the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
Délai: 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
|
|
Change From Baseline in Montreal Cognitive Assessment Score
Délai: 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.
|
Baseline to 1 week after completion of the 4-week intervention
|
|
Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
Délai: 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.
|
Baseline to 1 week after completion of the 4-week intervention
|
|
Glymphatic MRI marker
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Yue Huang, Beijing Tiantan Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
30 octobre 2027
Achèvement de l'étude (Estimé)
30 octobre 2027
Dates d'inscription aux études
Première soumission
6 août 2026
Première soumission répondant aux critères de contrôle qualité
6 août 2026
Première publication (Réel)
11 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HX-A-2025116
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Deidentified individual participant data underlying the results reported in the primary publication may be shared with qualified researchers upon reasonable request, following approval by the principal investigator and the institutional ethics committee.
Délai de partage IPD
Beginning 12 months after publication of the primary study results and available for 3 years.
Critères d'accès au partage IPD
Requests must include a scientifically sound research proposal and a statistical analysis plan.
Data access will require institutional approval and execution of a data use agreement.
Type d'informations de prise en charge du partage d'IPD
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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