Transcranial pulse stimulation to help people with early Alzheimer's disease

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.