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NOT YET RECRUITING
NCT07758751
NA

Multisensory 40-Hz Stimulation for Alzheimer's Disease

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09

Completion Date

2027-10-30

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.