Pulsed Electromagnetic Field Treatment With Dementia Patients

Launched by HERRICK MEDICAL LLC · Mar 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method using a pulsed electromagnetic field device for patients with mild to moderate Alzheimer's disease. The goal is to see if this device can help slow down the progression of the disease. Participants will use the treatment device at home three times a day for 15 minutes over a period of 120 days. Researchers will evaluate the effects of the treatment using tests that measure cognitive abilities, and they will follow up with participants for nine months after the treatment ends.

To be eligible for this study, participants must be at least 50 years old and have a diagnosis of mild to moderate Alzheimer's disease. They should also have a stable medication regimen if they are taking certain Alzheimer's medications. It's important that a family member or caregiver can help support the patient throughout the study. Participants will not be eligible if they have a history of certain neurological conditions, recent major surgeries, or specific metal implants in their heads. This trial is not yet recruiting, so interested patients should keep an eye out for when enrollment begins.

Gender

ALL

Eligibility criteria

• 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