By InvitationNot Applicable

Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease

China40 participantsStarted 2025-11-01

Plain-language 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. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.

Who can participate

Age range50 Years – 75 Years

SexALL

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Inclusion criteria

✓. According to the 2024 NIA-AA Revised Criteria , defined as positivity for at least one Core 1 biomarker:
✓. 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

✕. 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.

What they're measuring

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score

Timeframe: Baseline, End of treatment (2 weeks)

Trial details

NCT IDNCT07543094

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

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