Effects of magnetic stimulation on sleep and cognition in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of repetitive transcranial magnetic stimulation (rTMS) on sleep quality and cognitive function in patients with mild-to-moderate Alzheimer's disease. Participants will receive either real or sham rTMS treatment applied to the dorsolateral prefrontal cortex over a five-day period, with follow-up assessments at one and three months. The study aims to explore the role of the glymphatic system in mediating the relationship between sleep and cognitive function, utilizing neuropsychological testing, polysomnography, and magnetic resonance imaging as primary outcome measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant meets 2014 IWG-2 criteria for hippocampal amnestic syndrome, typical of AD, with progressive episodic memory impairment confirmed by neuropsychology. Cerebrospinal fluid markers (Aβ40, Aβ42, T-tau, p-tau) consistent with AD, or AV-45 PET imaging showing significant cortical tracer retention, in line with AD pathophysiology.
2. Age range: 55-80 years.
3. No visual or hearing impairment.
4. Right-handed.
5. Han nationality.
6. Signed informed consent.
7. Reliable caregivers as information providers.
8. MMSE score: 10-27; CDR: 0.5-2 points.
9. If receiving approved AD treatment (e.g., acetylcholinesterase inhibitor or memantine), dose must be stable for ≥3 months prior to screening and unchanged unless medically necessary.

Exclusion Criteria:

1. History of seizures or epilepsy diagnosis;
2. Stroke history;
3. Nervous system diseases causing brain dysfunction (schizophrenia, severe anxiety/depression, dementia, Huntington's, brain tumors, Parkinson's, metabolic encephalopathy, encephalitis, MS, epilepsy, brain trauma, hydrocephalus);
4. Severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent MI;
5. Barbiturate/benzodiazepine use within 2 weeks;
6. MRI/TMS contraindications (metallic implants);
7. Systemic diseases causing cognitive impairment (hypothyroidism, folate/B12 deficiency, infections, alcohol/drug abuse);
8. Aphasia, consciousness disturbance, inability to cooperate;
9. TMS/tDCS/DBS has been processed;
10. Underlying pathology other than AD;
11. Focal brain lesions on T1/T2 images;
12. Refusal to sign informed consent.

Where it's running

• The First Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Guoping Peng, Doctor
• Email: pgpfc@163.com
• Phone: 0571-87235859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.