Multisensory 40-Hz Stimulation for Alzheimer's Disease
6. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jinhui Yin, MD
- Telefonnummer: +8619801177703
- E-Mail: yjh_hw@163.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
|
Schein-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Yue Huang, Beijing Tiantan Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
30. Oktober 2027
Studienabschluss (Geschätzt)
30. Oktober 2027
Studienanmeldedaten
Zuerst eingereicht
6. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. August 2026
Zuerst gepostet (Tatsächlich)
11. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HX-A-2025116
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
Beginning 12 months after publication of the primary study results and available for 3 years.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .