Clinical trial NCT04333329: Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)
Official title: Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
Collaborators: name: Rheintalklinik
First posted: 2020-04-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
timeFrame: 3 months after treatment
measure: Adverse Device Effects
timeFrame: within 3 months follow-up
Secondary outcomes:
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
timeFrame: Immediately post treatment (at 2 weeks)
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
timeFrame: 1 month after treatment (at 6 weeks)
measure: Mini-Mental-State Examination (MMSE)
timeFrame: Immediately post treatment (at 2 weeks)
measure: Mini-Mental-State Examination (MMSE)
timeFrame: 1 month after treatment (at 6 weeks)
measure: Mini-Mental-State Examination (MMSE)
timeFrame: 3 months after treatment (at 14 weeks)
measure: Clock Drawing Test (CDT)
timeFrame: Immediately post treatment (at 2 weeks)
measure: Clock Drawing Test (CDT)
timeFrame: 1 month after treatment (at 6 weeks)
measure: Clock Drawing Test (CDT)
timeFrame: 3 months after treatment (at 14 weeks)
measure: Beck Depression Inventory (BDI)
timeFrame: Immediately post treatment (at 2 weeks)
measure: Beck Depression Inventory (BDI)
timeFrame: 1 month after treatment (at 6 weeks)
measure: Beck Depression Inventory (BDI)
timeFrame: 3 months after treatment (at 14 weeks)
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: Immediately post treatment (at 2 weeks)
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: 1 month after treatment (at 6 weeks)
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: 3 months after treatment (at 14 weeks)
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Rheintalklinik
state: Baden-Württemberg
Study officials:
affiliation: Rheintalklinik
name: Henning Lohse-Busch, MD
role: PRINCIPAL_INVESTIGATOR
References: