Pulsed Electromagnetic Field Treatment With Alzheimer's Disease Patients

Description

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.

Conditions

Alzheimer Disease and Alzheimer's Disease Related Dementias

Study Overview

Study Details

Study overview

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.

Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Controlled Pilot Study

Pulsed Electromagnetic Field Treatment With Alzheimer's Disease Patients

Condition
Alzheimer Disease and Alzheimer's Disease Related Dementias
Intervention / Treatment

-

Contacts and Locations

Boca Raton

University of Miami, Boca Raton, Florida, United States, 334233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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 Parkinson's Disease
  • 5. Has Frontotemporal Dementia
  • 6. Currently taking medication that lowers the seizure threshold, excluding blood thinners
  • 7. 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).
  • 8. 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
  • 9. Severe agitation that would interfere with study procedures
  • 10. 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
  • 11. 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
  • 12. Head anatomy that interferes with the fit of the treatment device
  • 13. Participation in another clinical trial within the previous 30 days
  • 14. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
  • 15. Criteria to exclude participants from the blood draw study:

Ages Eligible for Study

50 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Herrick Medical LLC,

Study Record Dates

2026-09-30