Alzheimer DiseaseNCT07758751
Multisensory 40-Hz Stimulation for Alzheimer's Disease
A study testing Multisensory 40-Hz Stimulation Device in people with Alzheimer Disease, run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Multisensory 40-Hz Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease
- Being tested
- Multisensory 40-Hz Stimulation Device, Sham Multisensory Stimulation
- Keywords
- Alzheimer's disease, Mild cognitive impairment, Gamma entrainment, 40-Hz stimulation, Multisensory stimulation
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory 40-Hz Stimulation DeviceDevice
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 StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Active Multisensory 40-Hz Stimulation | Active comparator | Not described Receives: Device: Multisensory 40-Hz Stimulation Device |
| Sham Multisensory Stimulation | Sham comparator | Not described Receives: Device: Sham Multisensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Montreal Cognitive Assessment Score
The Montreal Cognitive Assessment evaluates global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
Plasma phosphorylated tau 217 concentration will be measured in fasting blood samples using a prespecified validated assay.
Measured: Baseline to 1 week after completion of the 4-week intervention
Glymphatic MRI marker
The DTI-ALPS index will be calculated from diffusion magnetic resonance imaging as a noninvasive imaging marker related to water diffusivity along perivascular spaces.
Measured: Baseline to 1 week after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, huang yue, Beijing Tiantan Hospital
- Investigators
- Yue Huang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758751
- Sponsor's protocol ID
- HX-A-2025116
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07758751
- Acronym / sponsor ID
- HX-A-2025116
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, Mild cognitive impairment, Gamma entrainment, 40-Hz stimulation, Multisensory stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Multisensory 40-Hz Stimulation | Active comparator | Device: Multisensory 40-Hz Stimulation Device |
| Sham Multisensory Stimulation | Sham comparator | Device: Sham Multisensory Stimulation |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory 40-Hz Stimulation DeviceA 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 | Active Multisensory 40-Hz Stimulation |
| Sham Multisensory StimulationThe sham device will reproduce the appearance, setup, and duration of the active intervention but will not deliver synchronized 40-Hz auditory and visual stimulation. | Device | Sham Multisensory Stimulation |
Primary outcome
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
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.
Incidence of Treatment-Emergent Adverse Events
Time frame: 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.
4 secondary outcomes
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
Time frame: Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Montreal Cognitive Assessment Score
Time frame: Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
Time frame: Baseline to 1 week after completion of the 4-week intervention
Glymphatic MRI marker
Time frame: Baseline to 1 week after completion of the 4-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yue Huang principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory 40-Hz Stimulation Device in people with Alzheimer Disease, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinhui Yin, MD (+8619801177703, yjh_hw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.