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

Effects of Repetitive Transcranial Magnetic Stimulation on Sleep and Cognitive Function in Patients With Alzheimer's Disease: a Randomized, Double-blind, Controlled Study

This study is testing whether a type of magnetic treatment can improve sleep and thinking skills in people with mild-to-moderate Alzheimer's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06385106 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 55-80 with mild to moderate Alzheimer's disease and stable treatment for at least three months.

Not a fit: Patients with a history of seizures, stroke, or other significant nervous system diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve cognitive function and sleep quality in patients with Alzheimer's disease.

How similar studies have performed: Previous studies have shown positive effects of rTMS in Alzheimer's patients, but the specific focus on sleep disorders is less explored.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Guoping Peng, Doctor

Conditions Alzheimer Disease; sleep; Glymphatic System; Transcranial Magnetic Stimulation; cognitive impairment