An interventional study of ECHS AD Device in Alzheimer's Disease, Lewy Body Dementia and Vascular Dementia, sponsored by Herrick Medical LLC. Recruiting at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Herrick Medical LLC · Not applicable, Interventional, and Treatment
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.
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:
Any condition that may significantly increase risks associated with blood draws
Experimental intervention arm
Device: ECHS AD Device
Pulsed electromagnetic therapy device
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Time frame: Change between day 0, and 45, 90, 135, 180 days
Mini-Mental Status Exam (MMSE)
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Time frame: Change between day 0, and 45, 90, 135, 180 days
Quality of Life Scale
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame: Change between day 0, and 45, 90, 135, 180 days
Global Deterioration questionnaire
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame: Change between day 0, and 45, 90, 135, 180 days
Side-Effects Questionnaire
Self-report of side-effects
Time frame: Change between day 0, and 45, 90, 135, 180 days
Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)
CDR-SB assesses the severity and progression of dementia
Time frame: Change between day 0, and 90, 180 days
Plan to share: Undecided
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