Alzheimer DiseaseNCT07543094
Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease
A study testing Temporal Interference Stimulation in people with Alzheimer Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the 2024 NIA-AA Revised Criteria , defined as positivity for at least one Core 1 biomarker:
- Positive plasma p-tau217 test (positivity defined by clinically validated diagnostic cutoffs provided by the assay manufacturer); or
- Positive amyloid PET scan; or
- Abnormal cerebrospinal fluid (CSF) ratios, including p-tau181/Aβ42, t-tau/Aβ42, or Aβ42/40.
- Reference: Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169.
- Age between 50 and 75 years, inclusive.
Show all 10Show fewer
- Minimum of 6 years of formal education.
- Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
- MMSE≥21.
- Stable dosage of cognitive-enhancing medications (e.g., cholinesterase inhibitors and/or memantine) for at least 6 weeks prior to screening.
Who cannot join
- Current or past history of significant neurological disorders other than AD (e.g., epilepsy, stroke, multiple sclerosis), intracranial lesions, neurosurgery, or significant head trauma.
- Current use of medications that may substantially impair cognitive function (e.g., anticonvulsants, antipsychotics, benzodiazepines).
- Any contraindication for MRI or the stimulation device (e.g., metallic implants, pacemakers, severe claustrophobia).
- Significant structural brain abnormalities on MRI (e.g., hydrocephalus, stroke, or severe white matter lesions [Fazekas score ≥ 3]).
- Diagnosis of major depression or other active, uncontrolled psychiatric disorders.
- Any severe or unstable medical condition that, in the investigator's judgment, could compromise participant safety or study validity (e.g., cardiovascular, renal, hepatic, respiratory, active cancer), or a history of alcohol/substance dependence.
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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000025
About this study
Official title: A Randomized, Double-Blind, Controlled Trial to Evaluate the Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease
This study aims to investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.
- Conditions
- Alzheimer Disease
- Being tested
- Temporal Interference Stimulation, Sham Stimulation
- Keywords
- Alzheimer Disease, Temporal Interference 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.
Temporal Interference StimulationDevice
Device: The non-invasive brain stimulator NervioX is used to administer Temporal Interference Stimulation (TIS).
Stimulation Parameters:
Frequencies: 2000 Hz and 2005 Hz (resulting in a 5 Hz theta rhythm envelope). Stimulation Intensity: 1.0-2.0 mA (peak current). Stimulation Target: Bilateral hippocampus Session Duration: 40 minutes per session. Treatment Course: 5 sessions per week, for 2 consecutive weeks, totaling 10 sessions.
Sham StimulationDevice
Device: The same NervioX device is used.
Stimulation Parameters:
The device is programmed to deliver a real stimulation (1.0-2.0 mA) for the initial 30 seconds of the session to mimic the initial sensation experienced by the active group.
Subsequently, the current is automatically reduced to 0 mA for the remainder of the 40-minute session.
The device screen continues to display the stimulation as ongoing to maintain the blinding.
The session frequency and total course (5 sessions/week for 2 weeks, 10 sessions total) are identical to the active intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Not described Receives: Device: Temporal Interference Stimulation |
| Sham Temporal Interference Stimulation | Sham comparator | Not described Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score
The ADAS-Cog 11 is a rater-administered scale designed to assess the severity of cognitive dysfunction in Alzheimer's disease. The total score ranges from 0 to 70, with a lower score indicating better cognitive performance. The change from baseline to the end of treatment will be analyzed.
Measured: Baseline, End of treatment (2 weeks)
Secondary outcomes (9)
Change in Mini-Mental State Examination (MMSE) Score
The MMSE is a brief 30-point questionnaire used to screen for cognitive impairment. The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Montreal Cognitive Assessment (MoCA) Score
The MoCA is a widely used screening assessment for detecting mild cognitive impairment. The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
The CDR-SB is a numeric scale derived from the CDR global score, which provides a more detailed assessment of cognitive and functional performance across six domains. The total score ranges from 0 to 18, with a higher score indicating greater severity of dementia.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Shape Trails Test (STT) - Part A Time
The STT-A measures visual attention and processing speed. The time in seconds to complete the task is recorded, with a shorter time indicating better performance. This is a continuous measure without a predefined minimum/maximum range.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Shape Trails Test (STT) - Part B Time
The STT-B measures executive function, including task-switching and cognitive flexibility. The time in seconds to complete the task is recorded, with a shorter time indicating better performance. This is a continuous measure without a predefined minimum/maximum range.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Digit Span Test (DST) Score
The DST is a component of cognitive tests that assesses attention and working memory. It includes forward span (attention) and backward span (working memory). The forward span typically ranges from 0 to 16, and the backward span from 0 to 14, with a higher number of correct sequences indicating better function.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and severity of all AEs and SAEs will be collected and monitored throughout the study to evaluate the safety and tolerability of the intervention.
Measured: From baseline through study completion (up to 16 weeks)
Change in Functional Connectivity measured by Resting-state Functional Magnetic Resonance Imaging (rs-fMRI)
Changes in brain network connectivity (e.g., within the default mode network and hippocampal connectivity) will be assessed using rs-fMRI.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Theta Band Power measured by Electroencephalography (EEG)
Changes in neural oscillatory activity will be assessed using high-density EEG.
Measured: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543094
- Sponsor's protocol ID
- 2025-621
- Status last verified
- Oct 2025
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Trial to Evaluate the Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07543094
- Acronym / sponsor ID
- 2025-621
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Temporal Interference Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Apr 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 investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Device: Temporal Interference Stimulation |
| Sham Temporal Interference Stimulation | Sham comparator | Device: Sham Stimulation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- According to the 2024 NIA-AA Revised Criteria , defined as positivity for at least one Core 1 biomarker:
- Reference: Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169.
- Age between 50 and 75 years, inclusive.
- Minimum of 6 years of formal education.
- Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
Key exclusion criteria (6 listed)
- Current or past history of significant neurological disorders other than AD (e.g., epilepsy, stroke, multiple sclerosis), intracranial lesions, neurosurgery, or significant head trauma.
- Current use of medications that may substantially impair cognitive function (e.g., anticonvulsants, antipsychotics, benzodiazepines).
- Any contraindication for MRI or the stimulation device (e.g., metallic implants, pacemakers, severe claustrophobia).
- Significant structural brain abnormalities on MRI (e.g., hydrocephalus, stroke, or severe white matter lesions [Fazekas score ≥ 3]).
- Diagnosis of major depression or other active, uncontrolled 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 |
|---|---|---|
| Temporal Interference StimulationDevice: The non-invasive brain stimulator NervioX is used to administer Temporal Interference Stimulation (TIS). Stimulation Parameters: Frequencies: 2000 Hz and 2005 Hz (resulting in a 5 Hz theta rhythm envelope). Stimulation Intensity: 1.0-2.0 mA (peak current). Stimulation Target: Bilateral hippocampus Session Duration: 40 minutes per session. Treatment Course: 5 sessions per week, for 2 consecutive weeks, totaling 10 sessions. | Device | Temporal Interference Stimulation |
| Sham StimulationDevice: The same NervioX device is used. Stimulation Parameters: The device is programmed to deliver a real stimulation (1.0-2.0 mA) for the initial 30 seconds of the session to mimic the initial sensation experienced by the active group. Subsequently, the current is automatically reduced to 0 mA for the remainder of the 40-minute session. The device screen continues to display the stimulation as ongoing to maintain the blinding. The session frequency and total course (5 sessions/week for 2 weeks, 10 sessions total) are identical to the active intervention group. | Device | Sham Temporal Interference Stimulation |
Primary outcome
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score
Time frame: Baseline, End of treatment (2 weeks)
The ADAS-Cog 11 is a rater-administered scale designed to assess the severity of cognitive dysfunction in Alzheimer's disease. The total score ranges from 0 to 70, with a lower score indicating better cognitive performance. The change from baseline to the end of treatment will be analyzed.
9 secondary outcomes
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Shape Trails Test (STT) - Part A Time
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Shape Trails Test (STT) - Part B Time
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Digit Span Test (DST) Score
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From baseline through study completion (up to 16 weeks)
Change in Functional Connectivity measured by Resting-state Functional Magnetic Resonance Imaging (rs-fMRI)
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
Change in Theta Band Power measured by Electroencephalography (EEG)
Time frame: Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)
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 24 Apr 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.
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 Temporal Interference Stimulation in people with Alzheimer Disease, run by Ruijin Hospital 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 10 inclusion and 6 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 24 Apr 2026. 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?
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score (time frame: Baseline, End of treatment (2 weeks)). 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 24 Apr 2026.