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Keep this study
Lead
Storz Medical AG
With
Rheintalklinik
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)
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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