Alzheimer's Disease(AD)
Conditions
Brief 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. 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.
Interventions
DEVICETemporal Interference Stimulation
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.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination (MMSE) | 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. |
| Clinical Dementia Rating (CDR) | 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. |
| Hamilton anxiety scale (HAMA) | 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. |
Countries
China
Outcome results
None listed