Transcranial random noise stimulation for behavioral and psychological symptoms in Alzheimer's disease
Official title: Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
Run by Anhui Medical University · NCT07827196 · Data updated 2026-11-12
This trial tests whether high-frequency transcranial random noise stimulation can help people with early Alzheimer's disease who have BPSD, compared to a sham treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 84 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07827196 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with early Alzheimer's disease or related conditions, MMSE 10–27, CDR ≤ 2, on stable acetylcholinesterase inhibitor therapy for at least 3 months.
✕Probably not a fit
Individuals with more severe dementia, seizures history, implanted neurostimulators, or uncontrolled psychiatric conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind study assigns about 40 participants with early Alzheimer's disease to receive either high-frequency transcranial random noise stimulation (tRNS) or sham stimulation for 14 days. Participants undergo baseline and post-treatment cognitive assessments plus EEG to explore neural changes. Stimulation uses a 4×1 electrode montage with a central anode delivering 1.5 mA at 100–640 Hz, and surrounding electrodes delivering a quarter of that current; sham mimics ramping without ongoing current. All participants are evaluated for eligibility, receive standard care, and are followed under blinded conditions to isolate the effect of tRNS on cognitive and behavioral symptoms.
Why it matters
Potential benefit: If effective, tRNS could reduce BPSD symptoms and support cognitive function in Alzheimer's patients.
How similar studies have gone: Previous research with noninvasive brain stimulation has shown potential benefits in cognitive and behavioral symptoms, but this exact tRNS approach in BPSD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria. * Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia * CDR score ≤ 2 * Subject under treatment by IAChE for at least 3 months. * psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months Exclusion Criteria: * NPI ≥ 4 * CDR \> 2 * Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder). * History of head injury,stroke,or other neurologic disease. * Organic brain defects on T1 or T2 images. * History of seizures or unexplained loss of consciousness. * Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. * Family history of medication refractory epilepsy. * History of substance abuse within the last 6 months.
Where it's running
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Anhui Medical University, Hefei, Anhui 230032
Hefei, Anhui, China Recruiting
Study contacts
- Study coordinator: Kai Wang, PhD
- Email: wangkai1964@126.com
- Phone: +86-0551-62922263
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.