NCT06862557RecruitingNot Applicable
Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study
Herrick Medical LLC2 sites in 1 country48 target enrollmentStarted: April 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Age ≥ 50 years 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
- •If female, post-menopausal.
- •MMSE score between 16 and 26 (inclusive)
- •Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity
- •Able and willing to comply with the protocol
- •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)
- •Physical clearance for study participation as evaluated by the clinician
Exclusion Criteria
- •The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
- •The patient does not have a study partner who would be available for interview
- •History of epileptic seizures or epilepsy
- •Has Frontotemporal Dementia
- •Currently taking medication that lowers the seizure threshold, excluding blood thinners
- •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).
- •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
- •Severe agitation that would interfere with study procedures
- •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
- •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
- •Head anatomy that interferes with the fit of the treatment device
- •Participation in another clinical trial within the previous 30 days
- •Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
- •Criteria to exclude participants from the blood draw study:
- •Any condition that may significantly increase risks associated with blood draws
Arms & Interventions
Active ECHS AD device
Experimental
Experimental intervention arm
Intervention: ECHS AD Device (Device)
Outcomes
Primary Outcomes
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time Frame: 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 Outcomes
- Mini-Mental Status Exam (MMSE)(Change between day 0, and 45, 90, 135, 180 days)
- Quality of Life Scale(Change between day 0, and 45, 90, 135, 180 days)
- Global Deterioration questionnaire(Change between day 0, and 45, 90, 135, 180 days)
- Side-Effects Questionnaire(Change between day 0, and 45, 90, 135, 180 days)
- Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)(Change between day 0, and 90, 180 days)
Investigators
Study Sites (2)
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