Alzheimer s DiseaseNCT07208734
Personalized Brain Stimulation for Cognitive Impairment in Older Adults
A study testing Transcranial Alternating Current Stimulation (tACS) and AI-based Cognitive Training in people with Alzheimer s Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to develop and test new personalized treatments for older adults with cognitive impairment. Project 1: Create a personalized cognitive training program using computer algorithms to match training tasks to individual needs. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- Transcranial Alternating Current Stimulation (tACS) and AI-based Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Nov 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients or outpatients aged 50-90 years;
- Patients diagnosed with amnestic mild cognitive impairment (aMCI) due to AD or mild dementia due to AD, based on the 2018 NIA-AA clinical diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association;
- Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1;
- Able to communicate fluently in Chinese (non-illiterate);
- For those currently receiving cholinesterase inhibitor therapy (e.g., donepezil or rivastigmine), the treatment dose must be stable, defined as a fixed dosage administered continuously for at least six weeks, with no adjustment of the medication regimen during the study period;
- Provision of written informed consent.
Who cannot join
- Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging;
- Moderate to severe white matter lesions (Fazekas score 3-6);
- Presence of any cause of consciousness disorder;
- Severe aphasia or motor disability that prevents completion of neuropsychological assessments;
- Current psychiatric disorders;
- History of alcohol dependence, drug addiction, traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus, or other neurological disorders that may cause cognitive impairment;
- Systemic diseases that may contribute to mild cognitive impairment (e.g., hepatic or renal insufficiency, endocrine disorders, vitamin deficiencies);
- Considered unsuitable for participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053
Beijing, Beijing Municipality, 100053
About this study
Official title: Development and Multicenter Validation of a Personalized Transcranial Alternating Current Stimulation Protocol for Cognitive Impairment in Older Adults
This study aims to develop and test new personalized treatments for older adults with cognitive impairment.
Project 1: Create a personalized cognitive training program using computer algorithms to match training tasks to individual needs. About 300 participants will join a randomized trial at hospitals and community health centers.
Read more
Project 2: Develop a personalized brain stimulation program (tACS) based on brain imaging and artificial intelligence. About 160 participants will be enrolled to test safety and effectiveness.
Project 3: Build a framework for ethical data management by reviewing international practices and consulting experts.
Together, these projects will provide evidence for safe, effective, and personalized care, while ensuring responsible use of research data.
Read the detailed description
This study is designed to improve the treatment and care of older adults with cognitive impairment through three related projects.
Project 1: Development of a personalized cognitive training program. Using advanced computer algorithms, we will match training tasks to each patient's needs across multiple cognitive domains. About 300 participants will be enrolled from hospitals and community health centers in two provinces to test the effectiveness of this program in a randomized controlled trial.
Project 2: Development of a personalized brain stimulation program. Based on brain imaging data and artificial intelligence models, we will create individualized transcranial alternating current stimulation (tACS) plans to deliver precise, safe, and effective stimulation. About 160 participants will be recruited from the same sites to evaluate safety and effectiveness in a randomized controlled trial.
Project 3: Development of a data governance and ethics framework. Building on the first two projects, we will review international literature and consult experts in ethics, geriatrics, neuroscience, and data governance to create a framework for managing multimodal data and ethical issues in cognitive impairment research.
Together, these projects aim to provide personalized, scientifically validated treatment strategies and ensure that research data are managed safely and ethically.
- Conditions
- Alzheimer s Disease
- Being tested
- Transcranial Alternating Current Stimulation (tACS), AI-based Cognitive Training, Sham intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current Stimulation (tACS)Device
Gamma TranscraniaThis intervention uses a personalized transcranial alternating current stimulation (tACS) protocol specifically designed for older adults with cognitive impairment. Unlike standard brain stimulation approaches, this protocol is individualized through artificial intelligence-based modeling of each participant's brain imaging data to optimize electric field distribution. The study will evaluate both safety and effectiveness in a multicenter randomized controlled trial.l Alternating Current Stimulation (tACS)
AI-based Cognitive TrainingOther
This intervention provides a personalized cognitive training program tailored to multiple cognitive domains. Using algorithm-based task matching, the system delivers training exercises adapted to each participant's cognitive profile. The program is designed to target memory, attention, executive function, and language, and will be validated through a multicenter randomized controlled trial.
Sham interventionOther
The sham stimulation group will undergo the same setup procedures as the active tACS group, including electrode placement and device operation. However, no effective current will be delivered beyond an initial brief sensation, ensuring participants cannot distinguish sham from active stimulation. This allows blinding of participants and investigators to treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training | Experimental | Not described Receives: Device: Transcranial Alternating Current Stimulation (tACS); Other: AI-based Cognitive Training |
| Sham intervention | Sham comparator | Not described Receives: Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moca score
Measured: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.
Secondary outcomes (1)
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
Measured: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 May 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208734
- Sponsor's protocol ID
- 2025116
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Multicenter Validation of a Personalized Transcranial Alternating Current Stimulation Protocol for Cognitive Impairment in Older Adults
- ClinicalTrials.gov ID
- NCT07208734
- Acronym / sponsor ID
- 2025116
- Conditions
- Alzheimer s Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Oct 2025 (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 develop and test new personalized treatments for older adults with cognitive impairment.
Project 1: Create a personalized cognitive training program using computer algorithms to match training tasks to individual needs. About 300 participants will join a randomized trial at hospitals and community health centers.
Project 2: Develop a personalized brain stimulation program (tACS) based on brain imaging and artificial intelligence. About 160 participants will be enrolled to test safety and effectiveness.
Project 3: Build a framework for ethical data management by reviewing international practices and consulting experts.
Together, these projects will provide evidence for safe, effective, and personalized care, while ensuring responsible use of research data.
Detailed description
This study is designed to improve the treatment and care of older adults with cognitive impairment through three related projects.
Project 1: Development of a personalized cognitive training program. Using advanced computer algorithms, we will match training tasks to each patient's needs across multiple cognitive domains. About 300 participants will be enrolled from hospitals and community health centers in two provinces to test the effectiveness of this program in a randomized controlled trial.
Project 2: Development of a personalized brain stimulation program. Based on brain imaging data and artificial intelligence models, we will create individualized transcranial alternating current stimulation (tACS) plans to deliver precise, safe, and effective stimulation. About 160 participants will be recruited from the same sites to evaluate safety and effectiveness in a randomized controlled trial.
Project 3: Development of a data governance and ethics framework. Building on the first two projects, we will review international literature and consult experts in ethics, geriatrics, neuroscience, and data governance to create a framework for managing multimodal data and ethical issues in cognitive impairment research.
Together, these projects aim to provide personalized, scientifically validated treatment strategies and ensure that research data are managed safely and ethically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training | Experimental | Device: Transcranial Alternating Current Stimulation (tACS), Other: AI-based Cognitive Training |
| Sham intervention | Sham comparator | Other: Sham intervention |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatients or outpatients aged 50-90 years;
- Patients diagnosed with amnestic mild cognitive impairment (aMCI) due to AD or mild dementia due to AD, based on the 2018 NIA-AA clinical diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association;
- Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1;
- Able to communicate fluently in Chinese (non-illiterate);
- For those currently receiving cholinesterase inhibitor therapy (e.g., donepezil or rivastigmine), the treatment dose must be stable, defined as a fixed dosage administered continuously for at least six weeks, with no adjustment of the medication regimen during the study period;
Key exclusion criteria (8 listed)
- Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging;
- Moderate to severe white matter lesions (Fazekas score 3-6);
- Presence of any cause of consciousness disorder;
- Severe aphasia or motor disability that prevents completion of neuropsychological assessments;
- Current psychiatric disorders;
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 |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS)Gamma TranscraniaThis intervention uses a personalized transcranial alternating current stimulation (tACS) protocol specifically designed for older adults with cognitive impairment. Unlike standard brain stimulation approaches, this protocol is individualized through artificial intelligence-based modeling of each participant's brain imaging data to optimize electric field distribution. The study will evaluate both safety and effectiveness in a multicenter randomized controlled trial.l Alternating Current Stimulation (tACS) | Device | Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training |
| AI-based Cognitive TrainingThis intervention provides a personalized cognitive training program tailored to multiple cognitive domains. Using algorithm-based task matching, the system delivers training exercises adapted to each participant's cognitive profile. The program is designed to target memory, attention, executive function, and language, and will be validated through a multicenter randomized controlled trial. | Other | Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training |
| Sham interventionThe sham stimulation group will undergo the same setup procedures as the active tACS group, including electrode placement and device operation. However, no effective current will be delivered beyond an initial brief sensation, ensuring participants cannot distinguish sham from active stimulation. This allows blinding of participants and investigators to treatment allocation. | Other | Sham intervention |
Primary outcome
Moca score
Time frame: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.
1 secondary outcome
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
Time frame: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.
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 6 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation (tACS) and AI-based Cognitive Training in people with Alzheimer s Disease, run by Xuanwu Hospital, Beijing at 1 site 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 6 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moca score (time frame: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.). 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 6 Oct 2025.