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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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

Other trials in China

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.

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 groups in NCT07543094
Study groupRoleWhat they receive
Temporal Interference StimulationExperimentalNot described
Receives: Device: Temporal Interference Stimulation
Sham Temporal Interference StimulationSham comparatorNot described
Receives: Device: Sham Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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.

  1. First posted21 Apr 2026
  2. Study start1 Nov 2025
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT07543094.

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; AzTrials last refreshed its copy on 30 Oct 2026.

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