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Multisensory 40-Hz Stimulation for Alzheimer's Disease

6. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Jinhui Yin, MD
  • Telefonnummer: +8619801177703
  • E-post: yjh_hw@163.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Provision of written informed consent by the participant or the participant's legally authorized representative.
  2. Age 45 to 75 years, inclusive.
  3. Completion of at least primary school education.
  4. 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:

  1. 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.
  2. Contraindication to magnetic resonance imaging, electroencephalography, auditory stimulation, visual stimulation, or noninvasive brain stimulation.
  3. Current major depressive disorder or another psychiatric disorder that, in the investigator's judgment, may interfere with study participation or outcome assessment.
  4. Clinically significant structural abnormalities on brain magnetic resonance imaging, including hydrocephalus, stroke, or another structural lesion that may confound study results.
  5. Severe cardiovascular or pulmonary disease.
  6. Cognitive impairment primarily attributable to another disorder, including frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease dementia, or vascular dementia.
  7. Clinically significant suicide risk or a suicide attempt within the previous 12 months.
  8. Behavioral disturbance, including severe aggression, agitation, or impulsivity, that may interfere with adherence to study procedures.
  9. Current or planned treatment with an anti-amyloid monoclonal antibody during the study period.
  10. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Active Multisensory 40-Hz Stimulation
Enhet: Multisensory 40-Hz Stimulation Device
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.
Sham-komparator: Sham Multisensory Stimulation
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Tiantan Hospital

Etterforskere

  • Hovedetterforsker: Yue Huang, Beijing Tiantan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. oktober 2027

Studiet fullført (Antatt)

30. oktober 2027

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

6. august 2026

Først lagt ut (Faktiske)

11. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HX-A-2025116

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Beginning 12 months after publication of the primary study results and available for 3 years.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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