Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia
Conditions
Brief summary
An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.
Interventions
DEVICEECHS AD Device
Pulsed electromagnetic therapy device
Sponsors
Herrick Medical LLC
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Active treatment
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline. 3\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician
Exclusion criteria
1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent 2. The patient does not have a study partner who would be available for interview 3. History of epileptic seizures or epilepsy 4. Has Frontotemporal Dementia 5. Currently taking medication that lowers the seizure threshold, excluding blood thinners 6. Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit). 7. Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study 8. Severe agitation that would interfere with study procedures 9. Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation 10. Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of \>1 week hospitalization) within 4 weeks 11. Head anatomy that interferes with the fit of the treatment device 12. Participation in another clinical trial within the previous 30 days 13. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth 14. Criteria to exclude participants from the blood draw study: Any condition that may significantly increase risks associated with blood draws
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) | Change between day 0, and 45, 90, 135, 180 days | Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental Status Exam (MMSE) | Change between day 0, and 45, 90, 135, 180 days | Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity |
| Quality of Life Scale | Change between day 0, and 45, 90, 135, 180 days | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity |
| Global Deterioration questionnaire | Change between day 0, and 45, 90, 135, 180 days | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity |
| Side-Effects Questionnaire | Change between day 0, and 45, 90, 135, 180 days | Self-report of side-effects |
| Clinical Dementia Rating (CDR) sum of boxes (CDR-SB) | Change between day 0, and 90, 180 days | CDR-SB assesses the severity and progression of dementia |
Countries
United States
Contacts
CONTACTMagdalena Tolea, PhD
Outcome results
None listed