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NCT Number: NCT07694921

Effect and Safety of Non-invasive Electrical Stimulation 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.

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Key information

Conditions

Alzheimer's Disease(AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

temporal interference stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Mini-Mental State Examination (MMSE)

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

  2. Clinical Dementia Rating (CDR)

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

  3. Hamilton anxiety scale (HAMA)

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Effect and Safety of Non-invasive Electrical Stimulation in Improving Cognitive and Depressive Symptoms in Alzheimer's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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