Alzheimer Dementia (AD)NCT07618481
BCI With 40Hz Stimulation in Alzheimer's Disease
A study testing 40Hz Stimulation Group and Individualized Stimulation Group in people with Alzheimer Dementia (AD), run by Ruijin Hospital at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Dementia (AD)
- What is being tested?
- 40Hz Stimulation Group and Individualized Stimulation Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2026to 31 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
- Age between 50 and 80 years, inclusive.
- Positive Aβ-PET scan result.
- Has a stable caregiver who can assist with daily stimulation intervention.
- Chronic medical conditions stable for at least 30 days.
- Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).
- Good mobility (able to walk independently or with assistive devices).
- Willing and able to provide voluntary signed informed consent.
Who cannot join
- History of epilepsy or seizure disorder.
- Inability to undergo MRI or presence of significant abnormalities on MRI screening.
- Geriatric Depression Scale (GDS) score > 6.
- Current suicidal ideation or suicide attempt within the past 6 months.
- Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis/encephalitis) or multiple concussions; metabolic/systemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).
- Psychiatric disorders.
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- Severe cardiac disease, chronic liver/kidney/respiratory disease, or uncontrolled diabetes mellitus or thyroid disease.
- History of drug or alcohol abuse within the past 12 months.
- Current exposure to anti-Aβ antibody immunotherapies.
- Current use of memantine within 30 days prior to intervention.
- Life expectancy < 24 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000025
Chao Gao, +8618217590273, anshangaochao@163.com
Binyin Li, MD, Ph.D, +8613681884221, libinyin@126.com
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000025
Chao Gao, MD, Ph.D, +8618217590273, anshangaochao@163.com
Chao Gao, anshangaochao@163.com
About this study
Official title: EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study
This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.
- Conditions
- Alzheimer Dementia (AD)
- Being tested
- 40Hz Stimulation Group, Individualized Stimulation Group, Sham Stimulation Group
- Keywords
- Alzheimer's Disease, Non-Invasive Brain Stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40Hz Stimulation GroupDevice
Participants receive fixed 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. The stimulation parameters are fixed and do not adjust based on EEG feedback.
Individualized Stimulation GroupDevice
Participants receive 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. In addition, the device performs EEG acquisition and closed-loop feedback adjustment based on preset algorithms. This allows individualized, closed-loop neuromodulation.
Sham Stimulation GroupDevice
Participants receive sham stimulation using a device identical in appearance and weight to the active device. The sham device does not output effective individualized audio-visual stimulation; only low-intensity, randomized flashes and audio cues are delivered.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz Stimulation Group | Experimental | Fixed 40Hz combined audio-visual stimulation, 60 minutes per day, once daily, for 6 consecutive months. Receives: Device: 40Hz Stimulation Group |
| Individualized Stimulation Group | Experimental | 40Hz combined audio-visual stimulation with EEG-based closed-loop feedback adjustment, 60 minutes per day, once daily, for 6 consecutive months. Receives: Device: Individualized Stimulation Group |
| Sham Stimulation Group | Sham comparator | Identical appearance and operation as the active device, but without effective individualized audio-visual stimulation. Only low-intensity, randomized flashes and audio cues are delivered. Receives: Device: Sham Stimulation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment - Basic (MoCA-B) Score
The primary outcome is the change in MoCA-B score from baseline to 6 months. The MoCA-B is a validated cognitive screening tool for assessing global cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The change score (ΔMoCA-B) will be calculated as the 6-month score minus the baseline score. Assessments will be performed by trained neuropsychologists who are blinded to group assignment.
Measured: Baseline (pre-treatment) and 6 months (end of treatment)
Secondary outcomes (10)
Change in Auditory Verbal Learning Test (AVLT) Score
The AVLT is a validated neuropsychological test assessing verbal learning and memory function. The test evaluates immediate recall, delayed recall, and recognition. Higher scores indicate better verbal memory performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Measured: Baseline, 3 months, and 6 months
Change in Shape Trails Test (STT-A and STT-B) Score
The STT is a validated neuropsychological test assessing executive function, attention, and psychomotor speed. STT-A primarily measures processing speed, while STT-B measures executive function and task-switching ability. Lower completion time indicates better performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Measured: Baseline, 3 months, and 6 months
Change in Digit Span Test (DST) Score
The DST is a validated neuropsychological test assessing working memory and attention. The test includes forward digit span (attention) and backward digit span (working memory). Higher scores indicate better working memory performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Measured: Baseline, 3 months, and 6 months
Change in Structural MRI Parameters
Changes in structural brain imaging parameters will be assessed using 3T MRI, including gray matter volume, cortical thickness, and hippocampal volume. These parameters will be used to evaluate the neuroprotective effects of the intervention. Imaging data will be analyzed by neuroradiologists blinded to group assignment.
Measured: Baseline and 6 months
Change in Functional MRI (fMRI) Parameters
Changes in functional brain connectivity will be assessed using resting-state fMRI. Key parameters include functional connectivity within the default mode network (DMN) and gamma-band related networks. Imaging data will be analyzed by neuroradiologists blinded to group assignment.
Measured: Baseline and 6 months
Change in Peripheral Blood Alzheimer's Disease Biomarkers
Changes in peripheral blood biomarkers associated with Alzheimer's disease pathology will be assessed. Biomarkers include: (1) amyloid beta 42 (Aβ42); (2) amyloid beta 40 (Aβ40) and the Aβ42/Aβ40 ratio; (3) phosphorylated tau (p-Tau181 or p-Tau217); (4) total tau (t-Tau); (5) neurofilament light chain (NfL).
Measured: Baseline and 6 months
Change in Aβ-PET Standardized Uptake Value Ratio (SUVR)
Changes in brain amyloid beta burden will be assessed using Aβ-PET imaging. The primary measure is the standardized uptake value ratio (SUVR) in predefined regions of interest (including frontal, temporal, parietal, and occipital cortices, as well as the precuneus and cingulate). Higher SUVR indicates greater amyloid burden. Imaging data will be analyzed by nuclear medicine physicians blinded to group assignment.
Measured: Baseline and 6 months
Change in tau-PET Standardized Uptake Value Ratio (SUVR)
Changes in brain tau pathology will be assessed using tau-PET imaging. The primary measure is the standardized uptake value ratio (SUVR) in predefined regions of interest (including medial temporal lobe, temporal cortex, parietal cortex, and other Braak stage regions). Higher SUVR indicates greater tau burden. Imaging data will be analyzed by nuclear medicine physicians blinded to group assignment.
Measured: Baseline and 6 months
Incidence of Serious Adverse Events (SAEs)
The incidence, severity, and causality of all serious adverse events (SAEs) will be assessed throughout the study period. SAEs include: death, life-threatening events, persistent or significant disability or incapacity, hospitalization or prolonged hospitalization, fetal distress, fetal death, congenital anomalies or birth defects, and any other important medical events that may jeopardize the patient or require intervention to prevent one of the above outcomes.
Measured: Baseline through 6 months (entire study period)
Incidence of Adverse Events (AEs)
The incidence, severity, and causality of all adverse events (AEs) will be assessed throughout the study period. AEs include but are not limited to: transient dizziness, visual fatigue, headache, nausea, attention fluctuation, drowsiness, eye dryness, tinnitus, irritability, anxiety, and any other unexpected events. Severity will be graded as mild, moderate, or severe. Relationship to the intervention will be classified as: definitely related, possibly related, potentially related, possibly unrelated, or definitely unrelated.
Measured: Baseline through 6 months (entire study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 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 Dementia (AD)Studies of the same condition, open and under way.
- More trials run by Ruijin 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, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liu jun, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618481
- Sponsor's protocol ID
- 2026222
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07618481
- Acronym / sponsor ID
- 2026222
- Conditions
- Alzheimer Dementia (AD)
- Keywords
- Alzheimer's Disease, Non-Invasive Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Jun 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 efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40Hz Stimulation Group | Experimental | Device: 40Hz Stimulation GroupFixed 40Hz combined audio-visual stimulation, 60 minutes per day, once daily, for 6 consecutive months. |
| Individualized Stimulation Group | Experimental | Device: Individualized Stimulation Group40Hz combined audio-visual stimulation with EEG-based closed-loop feedback adjustment, 60 minutes per day, once daily, for 6 consecutive months. |
| Sham Stimulation Group | Sham comparator | Device: Sham Stimulation GroupIdentical appearance and operation as the active device, but without effective individualized audio-visual stimulation. Only low-intensity, randomized flashes and audio cues are delivered. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
- Age between 50 and 80 years, inclusive.
- Positive Aβ-PET scan result.
- Has a stable caregiver who can assist with daily stimulation intervention.
- Chronic medical conditions stable for at least 30 days.
Key exclusion criteria (11 listed)
- History of epilepsy or seizure disorder.
- Inability to undergo MRI or presence of significant abnormalities on MRI screening.
- Geriatric Depression Scale (GDS) score > 6.
- Current suicidal ideation or suicide attempt within the past 6 months.
- Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis/encephalitis) or multiple concussions; metabolic/systemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).
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 |
|---|---|---|
| 40Hz Stimulation GroupParticipants receive fixed 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. The stimulation parameters are fixed and do not adjust based on EEG feedback. | Device | 40Hz Stimulation Group |
| Individualized Stimulation GroupParticipants receive 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. In addition, the device performs EEG acquisition and closed-loop feedback adjustment based on preset algorithms. This allows individualized, closed-loop neuromodulation. | Device | Individualized Stimulation Group |
| Sham Stimulation GroupParticipants receive sham stimulation using a device identical in appearance and weight to the active device. The sham device does not output effective individualized audio-visual stimulation; only low-intensity, randomized flashes and audio cues are delivered. | Device | Sham Stimulation Group |
Primary outcome
Change in Montreal Cognitive Assessment - Basic (MoCA-B) Score
Time frame: Baseline (pre-treatment) and 6 months (end of treatment)
The primary outcome is the change in MoCA-B score from baseline to 6 months. The MoCA-B is a validated cognitive screening tool for assessing global cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The change score (ΔMoCA-B) will be calculated as the 6-month score minus the baseline score. Assessments will be performed by trained neuropsychologists who are blinded to group assignment.
10 secondary outcomes
Change in Auditory Verbal Learning Test (AVLT) Score
Time frame: Baseline, 3 months, and 6 months
Change in Shape Trails Test (STT-A and STT-B) Score
Time frame: Baseline, 3 months, and 6 months
Change in Digit Span Test (DST) Score
Time frame: Baseline, 3 months, and 6 months
Change in Structural MRI Parameters
Time frame: Baseline and 6 months
Change in Functional MRI (fMRI) Parameters
Time frame: Baseline and 6 months
Change in Peripheral Blood Alzheimer's Disease Biomarkers
Time frame: Baseline and 6 months
Change in Aβ-PET Standardized Uptake Value Ratio (SUVR)
Time frame: Baseline and 6 months
Change in tau-PET Standardized Uptake Value Ratio (SUVR)
Time frame: Baseline and 6 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline through 6 months (entire study period)
Incidence of Adverse Events (AEs)
Time frame: Baseline through 6 months (entire study period)
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 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40Hz Stimulation Group and Individualized Stimulation Group in people with Alzheimer Dementia (AD), run by Ruijin Hospital at 2 sites in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chao Gao (+8618217590273, anshangaochao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment - Basic (MoCA-B) Score (time frame: Baseline (pre-treatment) and 6 months (end of treatment)). 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 3 Jun 2026.