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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporal Interference Stimulation | Experimental |
| |
| Sham Temporal Interference Stimulation | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, End of treatment (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks) |
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Inclusion Criteria：
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.
MMSE≥21.
Stable dosage of cognitive-enhancing medications (e.g., cholinesterase inhibitors and/or memantine) for at least 6 weeks prior to screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 2000025 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Stimulation | Device | 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |