Alzheimer's Disease(AD)NCT07694921
Effect and Safety of Non-invasive Electrical Stimulation in Alzheimer's Disease
A study testing Temporal Interference Stimulation in people with Alzheimer's Disease(AD), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease(AD)
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 31 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Right-handed, Han ethnicity; (2) Meet the clinical diagnostic criteria for Alzheimer's disease as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Age ≥60 years, with at least primary school education, and capable of cooperating during testing; (4) Mini-Mental State Examination (MMSE) score <24; (5) Clinical Dementia Rating (CDR) score of 0.5 or 1; (6) The 24-item Hamilton Depression Scale (HAMD-24) score ≥20.
Who cannot join
- (1) Systemic diseases causing cognitive impairment, such as hypothyroidism, vitamin B12 or folic acid deficiency, and acquired immunodeficiency syndrome; (2) Comorbid neurological disorders including epilepsy, Parkinson's disease, normal-pressure hydrocephalus, and brain tumors; (3) Comorbid mental illnesses such as schizophrenia, bipolar disorder, or psychiatric disorders due to alcohol or drug abuse; (4) History of post-traumatic loss of consciousness, intracranial infection, or cerebrovascular disease; (5) A Hachinski Ischemic Scale (HIS) score ≥4; (6) Cranial MRI revealing ischemic lesions involving critical brain regions like the hippocampus, thalamus, basal ganglia, or angular gyrus, or multiple ischemic lesions in deep gray matter of the cerebral hemispheres; (7) Inability to undergo MRI due to special conditions such as internal metal implants or pacemakers.
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
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Effect and Safety of Non-invasive Electrical Stimulation in Improving Cognitive and Depressive Symptoms in Alzheimer's Disease
Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Temporal Interference Stimulation (TIS) is an emerging non-invasive electrical stimulation technique that precisely targets deep structures within the hippocampus through interference of multiple electric fields. This study will administer a two-week TIS treatment to patients with AD co-occurring depression, targeting the hippocampus, and compare changes in patients' cognitive function, scores on depression and anxiety scales, and functional magnetic resonance imaging (fMRI) data before and after treatment. An emotional word recall task will be administered during fMRI scans. The aim of this study is to investigate the efficacy, safety, and neural mechanisms of TIS-mediated modulation of hippocampal circuits in improving cognitive and emotional functioning in patients with AD and comorbid depression.
- Conditions
- Alzheimer's Disease(AD)
- Being tested
- 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
During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is Individualized.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Specific electrode sites are customized for the subject through magnetic resonance scanning, the Hippocampal region to be stimulated is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment. Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog)
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) is a brief, standardized, and widely used neuropsychological assessment designed to measure the severity of cognitive impairment, specifically the core symptoms of Alzheimer's disease (AD).Total Score Range:0 to 80. The higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 2 weeks
The 24-item Hamilton Depression Scale (HAMD-24)
The 24-item Hamilton Depression Scale (HAMD-24) is one of the most widely used clinician-administered questionnaires in psychiatry to assess the severity of depression.The total score ranges from 0 to 76, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (3)
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a brief, 30-point questionnaire used to screen for cognitive impairment. The total score ranges from 0 to 30, and higher scores mean a better outcome.
Measured: From enrollment to the end of treatment at 2 weeks
Clinical Dementia Rating (CDR)
The Clinical Dementia Rating (CDR) is a widely used numerical scale used to quantify the severity of symptoms of dementia. The total score ranges from 0 to 3, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 2 weeks
Hamilton anxiety scale (HAMA)
The Hamilton Anxiety Rating Scale (HAMA) is one of the first and most widely used clinician-rated scales designed to measure the severity of anxiety symptoms. The total score ranges from 0 to 56, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start16 Jun 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 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 Disease(AD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694921
- Sponsor's protocol ID
- IIT20250215C-R2
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Non-invasive Electrical Stimulation in Improving Cognitive and Depressive Symptoms in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07694921
- Acronym / sponsor ID
- IIT20250215C-R2
- Conditions
- Alzheimer's Disease(AD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 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.
Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Temporal Interference Stimulation (TIS) is an emerging non-invasive electrical stimulation technique that precisely targets deep structures within the hippocampus through interference of multiple electric fields. This study will administer a two-week TIS treatment to patients with AD co-occurring depression, targeting the hippocampus, and compare changes in patients' cognitive function, scores on depression and anxiety scales, and functional magnetic resonance imaging (fMRI) data before and after treatment. An emotional word recall task will be administered during fMRI scans. The aim of this study is to investigate the efficacy, safety, and neural mechanisms of TIS-mediated modulation of hippocampal circuits in improving cognitive and emotional functioning in patients with AD and comorbid depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Device: Temporal Interference StimulationSpecific electrode sites are customized for the subject through magnetic resonance scanning, the Hippocampal region to be stimulated is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Right-handed, Han ethnicity; (2) Meet the clinical diagnostic criteria for Alzheimer's disease as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Age ≥60 years, with at least primary school education, and capable of cooperating during testing; (4) Mini-Mental State Examination (MMSE) score <24; (5) Clinical Dementia Rating (CDR) score of 0.5 or 1; (6) The 24-item Hamilton Depression Scale (HAMD-24) score ≥20.
Key exclusion criteria (1 listed)
- (1) Systemic diseases causing cognitive impairment, such as hypothyroidism, vitamin B12 or folic acid deficiency, and acquired immunodeficiency syndrome; (2) Comorbid neurological disorders including epilepsy, Parkinson's disease, normal-pressure hydrocephalus, and brain tumors; (3) Comorbid mental illnesses such as schizophrenia, bipolar disorder, or psychiatric disorders due to alcohol or drug abuse; (4) History of post-traumatic loss of consciousness, intracranial infection, or cerebrovascular disease; (5) A Hachinski Ischemic Scale (HIS) score ≥4; (6) Cranial MRI revealing ischemic lesions involving critical brain regions like the hippocampus, thalamus, basal ganglia, or angular gyrus, or multiple ischemic lesions in deep gray matter of the cerebral hemispheres; (7) Inability to undergo MRI due to special conditions such as internal metal implants or pacemakers.
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 StimulationDuring the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is Individualized. | Device | Temporal Interference Stimulation |
Primary outcome
Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog)
Time frame: From enrollment to the end of treatment at 2 weeks
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) is a brief, standardized, and widely used neuropsychological assessment designed to measure the severity of cognitive impairment, specifically the core symptoms of Alzheimer's disease (AD).Total Score Range:0 to 80. The higher scores mean a worse outcome.
The 24-item Hamilton Depression Scale (HAMD-24)
Time frame: From enrollment to the end of treatment at 2 weeks
The 24-item Hamilton Depression Scale (HAMD-24) is one of the most widely used clinician-administered questionnaires in psychiatry to assess the severity of depression.The total score ranges from 0 to 76, and higher scores mean a worse outcome.
3 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: From enrollment to the end of treatment at 2 weeks
Clinical Dementia Rating (CDR)
Time frame: From enrollment to the end of treatment at 2 weeks
Hamilton anxiety scale (HAMA)
Time frame: From enrollment to the end of treatment at 2 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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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's Disease(AD), run by First Affiliated Hospital of Zhejiang University 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 1 inclusion and 1 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 27 Jul 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. 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?
Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog) (time frame: From enrollment to the end of treatment at 2 weeks). 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 27 Jul 2026.