Multisensory 40-Hz Stimulation for Alzheimer's Disease

NCT07758751 | Not Yet Recruiting

• 1 other identifier: HX-A-2025116
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; Mild cognitive impairment; Gamma entrainment; 40-Hz stimulation; Multisensory stimulation

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score

  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

  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

Secondary Outcomes (4)

• Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power

  Baseline to 1 week after completion of the 4-week intervention

• Change From Baseline in Montreal Cognitive Assessment Score

  Baseline to 1 week after completion of the 4-week intervention

• Change From Baseline in Plasma Phosphorylated Tau 217 Concentration

  Baseline to 1 week after completion of the 4-week intervention

• Glymphatic MRI marker

  Baseline to 1 week after completion of the 4-week intervention

Study Arms (2)

Active Multisensory 40-Hz Stimulation

ACTIVE COMPARATOR

Device: Multisensory 40-Hz Stimulation Device

Sham Multisensory Stimulation

SHAM COMPARATOR

Device: Sham Multisensory Stimulation

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.

Active Multisensory 40-Hz Stimulation

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.

Sham Multisensory Stimulation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Evidence of Alzheimer's disease pathology based on a positive positron emission tomography, cerebrospinal fluid, or blood biomarker result.
• Alzheimer's disease-related medications are expected to remain stable during the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Yue Huang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhui Yin, MD

CONTACT

+8619801177703; yjh_hw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Beginning 12 months after publication of the primary study results and available for 3 years.
• Access Criteria: 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.