Alzheimer Disease
Conditions
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)
Interventions
DEVICENEUROLITH
transcranial pulse stimulation (TPS)
Sponsors
Rheintalklinik
Storz Medical AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score | 3 months after treatment | CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning normal cognitive ability and 0 meaning severe cognitive impairment. |
| Adverse Device Effects | within 3 months follow-up | Number of ADEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clock Drawing Test (CDT) | Immediately post treatment (at 2 weeks) | The clock drawing test is used to assess visuoconstruction abilities. The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best). |
| Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score | Immediately post treatment (at 2 weeks) | CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning normal cognitive ability and 0 meaning severe cognitive impairment. |
| Geriatric Depression Scale - short form (GDS-15) | Immediately post treatment (at 2 weeks) | The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression). |
| Beck Depression Inventory (BDI) | Immediately post treatment (at 2 weeks) | The BDI measures the severity of depression. It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression). |
| Mini-Mental-State Examination (MMSE) | Immediately post treatment (at 2 weeks) | The MMSE consists of 10 items that cover orientation, short term memory, attentional capabilities, arithmetic performance and language functions. Scoring is possible between 0 (worst) and 30 (best). |
Countries
Germany
Outcome results
None listed