Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Recruiting · NCT06385106 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Zhejiang University
View the official record on ClinicalTrials.gov →Interventions studied
Real repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation
What this trial is about
Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD).
Who can take part
Age range
55 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Age range: 55-80 years.
- No visual or hearing impairment.
- Right-handed.
- Han nationality.
- Signed informed consent.
- Reliable caregivers as information providers.
- MMSE score: 10-27; CDR: 0.5-2 points.
- 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
- History of seizures or epilepsy diagnosis;
- Stroke history;
- 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);
- Severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent MI;
- Barbiturate/benzodiazepine use within 2 weeks;
- MRI/TMS contraindications (metallic implants);
- Systemic diseases causing cognitive impairment (hypothyroidism, folate/B12 deficiency, infections, alcohol/drug abuse);
- Aphasia, consciousness disturbance, inability to cooperate;
- TMS/tDCS/DBS has been processed;
- Underlying pathology other than AD;
- Focal brain lesions on T1/T2 images;
- Refusal to sign informed consent.
Where it is running
1 location listed.
- The First Affiliated Hospital of Zhejiang University - Hangzhou, Zhejiang, China