Transcranial pulse stimulation to help people with early Alzheimer's disease
A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects
We will test whether non-invasive transcranial pulse stimulation can improve thinking, memory, and behavior in people aged 60–90 with early Alzheimer's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07143734 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled pilot trial testing transcranial pulse stimulation (TPS) versus sham TPS in people with early-stage Alzheimer's disease. TPS is delivered intensively during the first two weeks with additional sessions at later intervals using a CE‑certified device. Outcomes include cognitive and neuropsychiatric rating scales, frontal near-infrared spectroscopy (fNIRS), and fasting blood tests measured at baseline and week 12. The trial is intended to provide preliminary safety and efficacy data to guide larger studies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60–90 with clinically diagnosed early-stage Alzheimer's who can give informed consent (with caregiver assistance if needed), can remain still for 30 minutes, and have a family caregiver available to participate in study activities.
Not a fit: Patients with advanced dementia, major neurological conditions (for example brain tumors, aneurysms), metal brain implants, bleeding disorders, active substance dependence, inability to consent or understand Chinese, or no available caregiver are unlikely to benefit from or be eligible for this study.
Why it matters
Potential benefit: If successful, TPS could slow cognitive decline and improve memory, daily function, or neuropsychiatric symptoms in people with early Alzheimer's disease.
How similar studies have performed: Small pilot studies and early reports of TPS in neurological conditions have shown promising cognitive and mood effects, but randomized large-scale evidence in Alzheimer's disease is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults who have been clinically diagnosed with Alzheimer's Disease in the early stage 2-6a according to the Functional Assessment Staging Test (In Appendix A) * The mental capacity to give informed consent for research is made by an experienced geriatrician based on Appendix A. * Aged 60-90 years old. * Able to make informed consent under assistance, which is witnessed and signed by a family caregiver. Exclusion Criteria: * Cannot understand Chinese. * Mentally incapacitated, unable to provide informed consent * Inability to remain still for 30 minutes * Lack of available family caregiver to answer questionnaires * Alcohol or substance dependence * Major neurological conditions, including: * Brain tumor * Brain aneurysm * Presence of any metal implants in the brain * Hemophilia or other blood clotting disorders * History of thrombosis
Where this trial is running
Hong Kong
- Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Timothy Chi Yui Kwok, PhD — Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong
- Study coordinator: KI SUM CHU, PhD candidate
- Email: sumkichu2015@link.cuhk.edu.hk
- Phone: (+852) 62087351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.