Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)

Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study

This is a prospective open comprehensive proof-of-principle pilot study.

This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)

Inclusion Criteria:

• Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
• MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
• At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
• Signed written informed consent
• 18 years ≤ Age ≤ 85 years
• Monthly pregnancy tests for female patients in childbearing age

Exclusion Criteria:

• Non-compliance with the protocol (including CERAD-plus)
• Pregnancy
• Breast-feeding women
• Microbubbles (contrast agents) in application area
• Cerebral pathology unrelated to Alzheimer's disease
• Metallic objects in the head
• Neurosurgical intervention of the brain / Craniotomy
• Cardiac disorders
• History of psychiatric diseases before development of dementia
• Hemophilia or other blood clotting disorders
• Cortisone treatment up to 6 months before first treatment
• Other conditions implying increased risk according to the judgement of the investigator