Multisensory 40-Hz Stimulation for Alzheimer's Disease

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07758751
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Multisensory 40-Hz Stimulation Device — 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 Multisensory Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Multisensory 40-Hz Stimulation
  • Sham Comparator: Sham Multisensory Stimulation

Primary Outcome Measure

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score [ Time Frame: Baseline to 1 week after completion of the 4-week intervention ]

Central Contacts

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